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)

Phase 3

Withdrawn

• Conditions: Chronic Hepatitis C Virus
• Interventions: Drug: Ombitasvir/paritaprevir/ritonavir

• Registration Number: NCT02806362
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-20
• Study Start: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05
• Primary Completion: 2018-06
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving a 12-week sustained virologic response (SVR12).	12 weeks after the last dose of study drug	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with on-treatment virologic failure	Up to Week 12	On-treatment virologic failure was defined as the following: Confirmed increase from nadir in HCV RNA (2 consecutive HCV RNA measurements greater than 1 log10 IU/mL above nadir) at any time point during treatment; or Confirmed HCV RNA greater than or equal to LLOQ after HCV RNA is less than LLOQ during treatment; or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks of treatment.
Percentage of participants with relapse	Up to 12 weeks after the last dose of study drug	Participants with a confirmed HCV RNA greater than or equal to the LLOQ between Final treatment visit and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA less than LLOQ at Final treatment visit.