An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease on Hemodialysis (GIFT-R)
Overview
- Phase
- Phase 3
- Intervention
- Ombitasvir/paritaprevir/ritonavir
- Conditions
- Chronic Hepatitis C Virus
- Sponsor
- AbbVie
- Primary Endpoint
- Percentage of participants achieving a 12-week sustained virologic response (SVR12).
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ombitasvir/paritaprevir/ritonavir (12 weeks)
Ombitasvir/paritaprevir/ritonavir (25/50/100mg once daily) for 12 weeks
Intervention: Ombitasvir/paritaprevir/ritonavir
Outcomes
Primary Outcomes
Percentage of participants achieving a 12-week sustained virologic response (SVR12).
Time Frame: 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 Outcomes
- 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)