Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

NCT02806362 | Withdrawn Phase 3

• 1 other identifier: M14-733
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.

Conditions

Chronic Hepatitis C Virus

Keywords

Non-cirrhotic; End Stage Renal Disease (ESRD); moderate fibrosis; Chronic Hepatitis C Virus ( HCV); Chronic Hepatitis C Genotype 1b

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving a 12-week sustained virologic response (SVR12).

  SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

  12 weeks after the last dose of study drug

Secondary Outcomes (2)

• Percentage of participants with on-treatment virologic failure

  Up to Week 12

• Percentage of participants with relapse

  Up to 12 weeks after the last dose of study drug

Study Arms (1)

Ombitasvir/paritaprevir/ritonavir (12 weeks)

EXPERIMENTAL

Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks

Drug: Ombitasvir/paritaprevir/ritonavir

Interventions

Ombitasvir/paritaprevir/ritonavir DRUG

Tablet

Ombitasvir/paritaprevir/ritonavir (12 weeks)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
• Hepatitis C Virus (HCV) Ribonucleic acid (RNA) greater than 10,000 IU/mL at Screening
• Chronic HCV, Genotype (GT)1b infection
• Treatment-naive or treatment-experienced with an interferon (IFN)-containing regimen (IFN or pegylated-IFN with or without ribavirin).
• A fibrosis assessment test result equivalent to Metavir F0-F2.

You may not qualify if:

• Presence of Y93H variant at Screening
• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab)
• Significant liver disease with any cause other than chronic HCV infection
• On peritoneal dialysis
• On hemodialysis for more than 15 years

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Kidney Failure, Chronic

Interventions

ombitasvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Koji Kato, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 5, 2016

Record last verified: 2016-12