Overview

This trial has been completed.

Conditions hcv, genotype 1a, genotype 4, chronic kidney disease, hepatitis c, pegifn, ifn
Treatments ombitasvir/paritaprevir/ritonavir, dasabuvir
Phase phase 3
Sponsor AbbVie
Start date September 2015
End date November 2016
Trial size 18 participants
Trial identifier NCT02487199, 2015-002012-33, M15-461

Summary

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adult genotype 1a or genotype 4 hepatitis C infected participants with severe kidney impairment or end-stage kidney disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Treatment with 3-DAA regimen
ombitasvir/paritaprevir/ritonavir
dasabuvir
(Active Comparator)
Treatment with 2-DAA regimen
ombitasvir/paritaprevir/ritonavir

Primary Outcomes

Measure
Percentage of participants with SVR12 in each arm
time frame: 12 weeks after last dose
Number of participants with Adverse Events
time frame: Screening until 30 days after last dose

Secondary Outcomes

Measure
Percentage of participants with on-treatment virologic failure in each treatment
time frame: Up to 12 weeks after first dose
Percentage of participants with post-treatment relapse within 12 weeks following end of treatment in each arm
time frame: Up to 12 weeks after last dose

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria

  • Chronic hepatitis C, genotype 1a infection or genotype 4 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 screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
  • 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

Additional Information

Official title An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by AbbVie.