Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

NCT03633227 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 747-401
• Study Type: interventional
• Target: 22
• Locations: 11 countries
• Sites: 38

Brief Summary

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

Conditions

Liver Cirrhosis, Biliary

Keywords

Primary Biliary Cholangitis; Primary Biliary Cirrhosis; PBC; Hepatic Impairment; Cirrhosis; Liver

Outcome Measures

Primary Outcomes (131)

• Maximum Observed Concentration (Cmax) of Total OCA at Week 12

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Time to Maximum Concentration (Tmax) of Total OCA at Week 12

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Trough Concentration (Ctrough) of Total OCA at Week 12

  Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  24 hours post-dose at Week 12

• Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Cmax of Total OCA at Week 18

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Tmax of Total OCA at Week 18

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Ctrough of Total OCA at Week 18

  Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  24 hours post-dose at Week 18

• AUC0-24h of Total OCA at Week 18

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Cmax of Total OCA at Week 24

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Tmax of Total OCA at Week 24

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Ctrough of Total OCA at Week 24

  Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  24 hours post-dose at Week 24

• AUC0-24h of Total OCA at Week 24

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Cmax of Total OCA at Week 30

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Tmax of Total OCA at Week 30

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Ctrough of Total OCA at Week 30

  Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  24 hours post-dose at Week 30

• AUC0-24h of Total OCA at Week 30

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Cmax of Total OCA at Week 48

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Tmax of Total OCA at Week 48

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Ctrough of Total OCA at Week 48

  Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

  24 hours post-dose at Week 48

• AUC0-24h of Total OCA at Week 48

  Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Cmax of Unconjugated OCA at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Tmax of Unconjugated OCA at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Ctrough of Unconjugated OCA at Week 12

  Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

  24 hours post-dose at Week 12

• AUC0-24h of Unconjugated OCA at Week 12

  AUC0-24 was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Cmax of Unconjugated OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Tmax of Unconjugated OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Ctrough of Unconjugated OCA at Week 18

  Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

  24 hours post-dose at Week 18

• AUC0-24h of Unconjugated OCA at Week 18

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Cmax of Unconjugated OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Tmax of Unconjugated OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Ctrough of Unconjugated OCA at Week 24

  Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

  24 hours post-dose at Week 24

• AUC0-24h of Unconjugated OCA at Week 24

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Cmax of Unconjugated OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Tmax of Unconjugated OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Ctrough of Unconjugated OCA at Week 30

  Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

  24 hours post-dose at Week 30

• AUC0-24h of Unconjugated OCA at Week 30

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Cmax of Unconjugated OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Tmax of Unconjugated OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Ctrough of Unconjugated OCA at Week 48

  Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

  24 hours post-dose at Week 48

• AUC0-24h of Unconjugated OCA at Week 48

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Tmax of Glyco-OCA at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Ctrough of Glyco-OCA at Week 12

  Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

  24 hours post-dose at Week 12

• AUC0-24h of Glyco-OCA at Week 12

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12

  MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12

  MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Cmax of Glyco-OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Tmax of Glyco-OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Ctrough of Glyco-OCA at Week 18

  Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

  24 hours post-dose at Week 18

• AUC0-24h of Glyco-OCA at Week 18

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRAUC of Glyco-OCA at Week 18

  MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRCmax of Glyco-OCA at Week 18

  MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Cmax of Glyco-OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Tmax of Glyco-OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Ctrough of Glyco-OCA at Week 24

  Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

  24 hours post-dose at Week 24

• AUC0-24h of Glyco-OCA at Week 24

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRAUC of Glyco-OCA at Week 24

  MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRCmax of Glyco-OCA at Week 24

  MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Cmax of Glyco-OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Tmax of Glyco-OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Ctrough of Glyco-OCA at Week 30

  Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

  24 hours post-dose at Week 30

• AUC0-24h of Glyco-OCA at Week 30

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRAUC of Glyco-OCA at Week 30

  MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRCmax of Glyco-OCA at Week 30

  MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Cmax of Glyco-OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Tmax of Glyco-OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Ctrough of Glyco-OCA at Week 48

  Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

  24 hours post-dose at Week 48

• AUC0-24h of Glyco-OCA at Week 48

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRAUC of Glyco-OCA at Week 48

  MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRCmax of Glyco-OCA at Week 48

  MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Tmax of Tauro-OCA at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Ctrough of Tauro-OCA at Week 12

  Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

  24 hours post-dose at Week 12

• AUC0-24h of Tauro-OCA at Week 12

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• MRAUC of Tauro-OCA at Week 12

  MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• MRCmax of Tauro-OCA at Week 12

  MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Cmax of Tauro-OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Tmax of Tauro-OCA at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Ctrough of Tauro-OCA at Week 18

  Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

  24 hours post-dose at Week 18

• AUC0-24h of Tauro-OCA at Week 18

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRAUC of Tauro-OCA at Week 18

  MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRCmax of Tauro-OCA at Week 18

  MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Cmax of Tauro-OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Tmax of Tauro-OCA at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Ctrough of Tauro-OCA at Week 24

  Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

  24 hours post-dose at Week 24

• AUC0-24h of Tauro-OCA at Week 24

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRAUC of Tauro-OCA at Week 24

  MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRCmax of Tauro-OCA at Week 24

  MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Cmax of Tauro-OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Tmax of Tauro-OCA at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Ctrough of Tauro-OCA at Week 30

  Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

  24 hours post-dose at Week 30

• AUC0-24h of Tauro-OCA at Week 30

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRAUC of Tauro-OCA at Week 30

  MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRCmax of Tauro-OCA at Week 30

  MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Cmax of Tauro-OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Tmax of Tauro-OCA at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Ctrough of Tauro-OCA at Week 48

  Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

  24 hours post-dose at Week 48

• AUC0-24h of Tauro-OCA at Week 48

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRAUC of Tauro-OCA at Week 48

  MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRCmax of Tauro-OCA at Week 48

  MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Tmax of OCA-glucuronide at Week 12

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Ctrough of OCA-glucuronide at Week 12

  Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

  24 hours post-dose at Week 12

• AUC0-24h of OCA-glucuronide at Week 12

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• MRAUC of OCA-glucuronide at Week 12

  MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• MRCmax of OCA-glucuronide at Week 12

  MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

• Cmax of OCA-glucuronide at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Tmax of OCA-glucuronide at Week 18

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Ctrough of OCA-glucuronide at Week 18

  Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

  24 hours post-dose at Week 18

• AUC0-24h of OCA-glucuronide at Week 18

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRAUC of OCA-glucuronide at Week 18

  MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• MRCmax of OCA-glucuronide at Week 18

  MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

• Cmax of OCA-glucuronide at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Tmax of OCA-glucuronide at Week 24

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Ctrough of OCA-glucuronide at Week 24

  Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

  24 hours post-dose at Week 24

• AUC0-24h of OCA-glucuronide at Week 24

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRAUC of OCA-glucuronide at Week 24

  MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• MRCmax of OCA-glucuronide at Week 24

  MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

• Cmax of OCA-glucuronide at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Tmax of OCA-glucuronide at Week 30

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Ctrough of OCA-glucuronide at Week 30

  Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

  24 hours post-dose at Week 30

• AUC0-24h of OCA-glucuronide at Week 30

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRAUC of OCA-glucuronide at Week 30

  MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• MRCmax of OCA-glucuronide at Week 30

  MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

• Cmax of OCA-glucuronide at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Tmax of OCA-glucuronide at Week 48

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Ctrough of OCA-glucuronide at Week 48

  Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

  24 hours post-dose at Week 48

• AUC0-24h of OCA-glucuronide at Week 48

  AUC0-24h was calculated using the linear/linear trapezoidal rule.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRAUC of OCA-glucuronide at Week 48

  MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• MRCmax of OCA-glucuronide at Week 48

  MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

  Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. An SAE was any AE that results in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in in-patient hospitalization or prolonged an existing hospitalization, was a congenital anomaly/birth defect, or was an important medical event that could jeopardize the participant or could have required medical intervention to prevent one of the outcomes listed above. TEAE was defined as any AE if it met one or more of the following criteria: 1) An AE started on or after the first study drug dose and within 30 days after the last dose of study drug, 2) An AE occurred prior to the first study drug dose that worsens (increase in grade) after the first study drug dose.

  Baseline up to approximately 3 years

Secondary Outcomes (22)

• Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

  Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

• Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

  Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

• Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

  Baseline, Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

• Number of Participants by Child-Pugh Score Component Category (Ascites Categories)

  Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

• Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories)

  Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

Study Arms (2)

Obeticholic Acid (OCA)

EXPERIMENTAL

Participants will initiate treatment with OCA 5 milligrams (mg) tablets orally once weekly. At Week 12, if there are no safety concerns, the dose will be up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose will be considered. At each titration visit, the participants will start the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration will be OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration will be 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).

Drug: Obeticholic Acid (OCA)

Placebo

PLACEBO COMPARATOR

Participants will receive OCA matching placebo orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).

Drug: Placebo

Interventions

Obeticholic Acid (OCA) DRUG

OCA will be administered per dose and schedule specified in the arm description.

Also known as: 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747

Obeticholic Acid (OCA)

Placebo DRUG

OCA matching placebo will be administered per the schedule specified in the arm description.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases \[AASLD\] and European Association for the Study of the Liver \[EASL\] Practice Guidelines, defined as having ≥2 of the following 3 diagnostic factors:
• History of elevated alkaline phosphatase (ALP) levels for at least 6 months
• Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (≤1:80), PBC specific antibodies (anti-glycoprotein 210 \[GP210\] and/or anti-SP100) and/or antibodies against the major M2 components (E2 component of mitochondrial pyruvate dehydrogenase complex \[PDC-E2\], 2-oxo-glutaric acid dehydrogenase complex)
• Liver biopsy consistent with PBC (collected at any time prior to Screening)
• Evidence of cirrhosis including at least one of the following:
• Biopsy results consistent with PBC Stage 4
• Liver stiffness as assessed by Transient Elastography (TE) Median Value ≥16.9 kilopascals (kPa)
• Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly)
• Combined low platelet count (\<140,000/cubic millimeter \[mm\^3\]) with
• persistent decrease in serum albumin, or
• elevation in prothrombin time/international normalized ratio (INR) (not due to antithrombotic agent use), or
• elevated bilirubin (2\*upper limit of normal \[ULN\])
• Satisfy the criteria of the modified Child-Pugh (CP) classification for hepatic impairment during Screening:
• Moderate: CP-B (Scores 7 to 9) or
• Severe: CP-C (Scores 10 to 12)

You may not qualify if:

• Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
• History of liver transplant or organ transplant
• History of alcohol or drug abuse within 12 months prior to Screening
• Hepatic encephalopathy (as defined by a West Haven score of ≥2
• History or presence of other concomitant liver diseases including:
• Hepatitis C virus infection and ribonucleic acid (RNA) positive
• Active hepatitis B infection; however, participants who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
• Primary sclerosing cholangitis
• Alcoholic liver disease
• Definite autoimmune liver disease or overlap hepatitis
• Gilbert's Syndrome
• In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic function prior to randomization

Sponsors & Collaborators

• Intercept Pharmaceuticals: lead

Study Sites (40)

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

University of California, Ddavis Medical Center

Sacramento, California, 95817, United States

Location

Schiff Center for Liver Diseases/ University of Miami

Miami, Florida, 33136, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

UPMC Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Baylor College of Medicine- Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

American Research Corporation at theTexas Liver Institute

San Antonio, Texas, 78215, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Universitario Austral

Buenos Aires, Argentina

Location

Hospital Aleman

Caba, Argentina

Location

Hospital Britanico de Buenos Aires

Caba, Argentina

Location

Hospital de Gastroenterologia "Dr Carlos Bonorino Udaondo"

Ciudad Autonoma de Buenos Aire, Argentina

Location

Higea S.A.

Mendoza, M5500DPS, Argentina

Location

Hospital Universitario Austral

Pilar, Argentina

Location

Hospital Provincial del Centenario

Rosario, Argentina

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Nepean Hospital

Kingswood, 2747, Australia

Location

CUB Hospital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen UZA

Edegem, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Hospital das Clínicas da Universidade Federal de Minas Gerais - UFMG

Belo Horizonte, Brazil

Location

Hospital de Clinicas de Porto Alegre

Rio Grande, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 054003-000, Brazil

Location

Toronto General Hospital

Toronto, Canada

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Universitatsklinikum Leipzig AoR

Leipzig, 04103, Germany

Location

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat-Gasztroenterologia-Hepatologia

Békéscsaba, Hungary

Location

Azienda Socio Sanitaria Territoriale (ASST) di Monza

Monza, MB, 20900, Italy

Location

AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica

Modena, 41126, Italy

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, Lithuania

Location

Klaipeda Seamen's Hospital

Klaipėda, LT-92288, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Paseo Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari I Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Related Publications (3)

• Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.

  PMID: 19554543 BACKGROUND

• European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.

  PMID: 19501929 BACKGROUND

• Vilstrup H, Amodio P, Bajaj J, Cordoba J, Ferenci P, Mullen KD, Weissenborn K, Wong P. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014 Aug;60(2):715-35. doi: 10.1002/hep.27210. Epub 2014 Jul 8. No abstract available.

  PMID: 25042402 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Fibrosis

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information
• Organization: Intercept Pharmaceuticals, Inc.

medinfo@interceptpharma.com

+1 844-782-4278

Study Officials

• Steven Shiff, M.D.

  Intercept Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: August 16, 2018
• Study Start: June 22, 2018
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: September 6, 2022
• Results First Posted: September 6, 2022

Record last verified: 2022-08

Locations

ES (3); BR (3); DE (1); US (11); AU (2); IT (2); LI (3); BE (3); CA (1); AR (8); HU (1)