Overview

This trial has been completed.

Conditions hepatitis c infection, hepatitis c virus
Treatments ombitasvir/paritaprevir/ritonavir, dasabuvir
Phase phase 3
Sponsor AbbVie
Start date November 2015
End date August 2016
Trial size 166 participants
Trial identifier NCT02582632, 2015-003370-33, M15-684

Summary

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

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/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
ombitasvir/paritaprevir/ritonavir ABT-267/ABT-450/r
Tablet
dasabuvir ABT-333
Tablet

Primary Outcomes

Measure
Percentage of participants who achieve sustained virologic response 12 weeks post-treatment (SVR12)
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 8 weeks while on treatment
Percentage of participants with post-treatment relapse
time frame: Up to 12 weeks after last dose of study drug
Percentage of female participants who achieve sustained virologic response 12 (SVR12) weeks post-treatment
time frame: 12 weeks after the last actual dose of study drug
Percentage of participants with low baseline viral load who achieve sustained virologic response 12 (SVR12) weeks post-treatment
time frame: Baseline and 12 weeks after the last actual dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: 1. Chronic HCV infection at Screening. 2. Screening laboratory result indicating HCV genotype 1b infection. 3. Treatment-naïve and non-cirrhotic. Exclusion Criteria: 1. HCV genotype or subtype other than GT1b. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) (test). 3. Any current or past clinical evidence of cirrhosis. 4. Screening laboratory analyses that shows abnormal results. 5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Additional Information

Official title An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by AbbVie.