Overview

This trial has been completed.

Conditions chronic hepatitis c, cirrhosis, hepatitis c virus
Treatments ombitasvir, paritaprevir, ritonavir, dasabuvir, ribavirin
Phase phase 3
Sponsor AbbVie
Start date May 2015
End date August 2016
Trial size 99 participants
Trial identifier NCT02442284, M14-251

Summary

This is a study to evaluate the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

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)
ombitasvir(OBV)/paritaprevir(PTV)/ritonavir(r) and dasabuvir(DSV) with or without Ribavirin (RBV) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.
ombitasvir
paritaprevir
ritonavir
dasabuvir
ribavirin

Primary Outcomes

Measure
Percentage of participants 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 participants with virologic failure during treatment
time frame: Up to 24 weeks while on treatment
Percentage of participants with virologic relapse post-treatment
time frame: Up to 24 weeks after last actual dose of study drug
Percentage of participants with Sustained Virologic Response 12 weeks post-treatment among participants with ongoing psychiatric disorders
time frame: 12 weeks after the last actual dose of study drug

Eligibility Criteria

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

Inclusion Criteria: 1. US military veteran currently receiving healthcare through the Veterans Health Administration 2. Screening laboratory result indicating HCV, genotype 1-infection 3. Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease) Exclusion Criteria: 1. Women who are pregnant or breastfeeding 2. Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) 3. Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir 4. Any current or past clinical evidence of Child-Pugh B or C classification 5. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis

Additional Information

Official title An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.