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)

• Status: Withdrawn
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ritonavir

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