Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

• Status: Completed
• Trial end date: 2016-12-05
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).

• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.

• Chronic kidney disease stage 4 or stage 5.

Exclusion Criteria:

• Females who are pregnant or breastfeeding

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)

• HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.

• Abnormal laboratory tests

• Current enrollment in another investigational study

• Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin

• Current treatment with a direct acting antiviral agent (DAA) containing regimen

• Any evidence of liver cirrhosis or liver cancer