NCT04956328

Brief Summary

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with PBC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 22, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 1, 2021

Last Update Submit

July 23, 2021

Conditions

Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of PBC patients reaching the compound endpoint after 48 weeks of treatment (Compound endpoint: alkaline phosphatase (ALP) < 1.67× Upper Limit of Normal(ULN), ALP decrease by at least 15% , and total bilirubin ≤ ULN )

    Compound endpoint: ALP \< 1.67× ULN, ALP decrease by at least 15% , and total bilirubin ≤ ULN

    up to 48 weeks

Secondary Outcomes (2)

  • Percentage of PBC patients reaching the compound endpoint after 4 weeks, 12 weeks, 24 weeks and 36 weeks of treatment (Compound endpoint: ALP < 1.67× ULN, ALP decrease by at least 15% , and total bilirubin ≤ ULN )

    up to 36 weeks

  • Rate of change of liver function indicators from baseline

    up to 48 weeks

Study Arms (2)

OCA Tablets 5-10 mg

EXPERIMENTAL

OCA 5 mg once daily in combination with UDCA for 24 weeks and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.

Drug: Obeticholic Acid TabletsDrug: UDCA

Placebo

PLACEBO COMPARATOR

Placebo once daily in combination with UDCA for 48 weeks.

Drug: UDCADrug: Placebo

Interventions

Obeticholic Acid TabletsDRUG

Obeticholic Acid：Once a day (QD) by mouth (PO).

OCA Tablets 5-10 mg
UDCADRUG

UDCA：continue prestudy dose

OCA Tablets 5-10 mgPlacebo
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 to 75 years.
  • Meet at least 2 of the following 3 PBC diagnoses:
  • Patients had elevated alkaline phosphatase for at least 3 months before enrolment.
  • AMA positive (titer ≥1:40), or if AMA negative, PBC specific antibodies (anti- GP210 and/or anti-SP100 and/or AMA-M2) are required.
  • Liver biopsy suggested PBC 48 weeks before enrollment.
  • ALP \> 1.67× ULN before enrollment.
  • Taking UDCA with stable dose for at least 3 months before enrollment.

You may not qualify if:

  • Merging with other virus infected.
  • With other existing liver disease or a history of liver disease.
  • With clinical complications of PBC or clinically significant hepatic decompensation.
  • Child-pugh grade B or C.
  • Creatinine (Cr) ≥ 1.5×ULN and serum creatinine clearance rate \< 60mL/min; \[Calculation formula: Cr:(140-age)×weight(kg) /0.818 × Scr (μmol/L)，female Cr=Cr × 0.85\].
  • ALT or AST\>5×ULN;Tbil \> 2×ULN.
  • Patients with a history of severe pruritus 2 months before enrollment.
  • The presence of clinically relevant arrhythmias or associated history that may affect survival during the study period.
  • With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Junqi Niu, Professor

CONTACT

13756661205junqiniu@aliyun.com

Study Design

Study Type
interventional
Phase
phase 3
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

July 1, 2021

First Posted

July 9, 2021

Study Start

July 22, 2021

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

CN(1)