Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus, compensated cirrhosis, severe renal impairment, end-stage renal disease
Treatments ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
Phase phase 3
Sponsor AbbVie
Start date September 2014
End date December 2016
Trial size 70 participants
Trial identifier NCT02207088, 2014-001527-77, M14-226

Summary

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Genotype 1a or 1b infected, treatment-naive or IFN treatment experienced subjects with renal impairment, with or without cirrhosis
ombitasvir/paritaprevir/ritonavir ABT-450/r/ABT-267
tablet
dasabuvir ABT-333
tablet
ribavirin RBV
tablet

Primary Outcomes

Measure
Percentage of subjects with Sustained Virologic Response 12 weeks post-treatment
time frame: 12 Weeks after the last actual dose of study drug

Secondary Outcomes

Measure
Percentage of subjects with on-treatment virologic failure
time frame: Up to 12 weeks
Percentage of subjects with post-treatment relapse
time frame: Within 12 weeks after the last dose of study drug

Eligibility Criteria

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

Inclusion Criteria: 1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening. 2. Screening laboratory result indicating HCV genotype 1 infection. 3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment). 4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab). 3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Additional Information

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