Overview

This trial is active, not recruiting.

Condition hepatitis c virus
Treatment abt-450/r/abt-267
Phase phase 3
Sponsor AbbVie
Start date December 2013
End date October 2014
Trial size 312 participants
Trial identifier NCT02023099, M13-004

Summary

This is a Phase 3, double blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Double-blind active 12 weeks treatment in subjects without compensated cirrhosis
abt-450/r/abt-267
(Placebo Comparator)
Double-blind placebo 12 weeks treatment followed by Open-label active 12 weeks treatment in subjects without compensated cirrhosis
abt-450/r/abt-267
(Experimental)
Open-label active 12 weeks treatment in subjects with compensated cirrhosis
abt-450/r/abt-267

Primary Outcomes

Measure
Percentage of non-cirrhotic treatment-naive subjects who are eligible for Interferon (IFN)-based therapy and who have high viral load in the active treatment group with a sustained virologic response 12 weeks post-treatment
time frame: 12 weeks after the last dose of study drug

Secondary Outcomes

Measure
The percentage of subjects in the active group with on-treatment virologic failure during treatment.
time frame: up to 12 weeks
The percentage of subjects in the active treatment group with post-treatment relapse
time frame: within 12 weeks after last dose of study drug
Percentage of subjects in the active treatment group with sustained virologic response 12 weeks post-treatment within different subpopulations
time frame: 12 weeks after last dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Chronic HCV-infection prior to study enrollment - Screening laboratory result indicating HCV subgenotype 1b infection - Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening - Voluntarily sign an informed consent Exclusion Criteria: - Co-infection of Hepatitis B Virus (HBV), HIV and any HCV genotype other than subgenotype 1b - Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir - Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: - Hemochromatosis - Alpha-1 antitrypsin deficiency - Wilson's disease - Autoimmune hepatitis - Alcoholic liver disease - Drug-related liver disease - Clinically significant laboratory abnormalities - Uncontrolled clinically significant disease, disorder or medical illness

Additional Information

Official title A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I)
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by AbbVie.