Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c virus, hepatitis c virus
Treatments abt-493/abt-530, ombitasvir/paritaprevir/ritonavir
Phase phase 3
Sponsor AbbVie
Start date February 2016
End date December 2016
Trial size 245 participants
Trial identifier NCT02707952, M15-594

Summary

The purpose of this study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic hepatitis C virus infection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-493/ABT-530 in HCV GT1 infected participants for 8 weeks
abt-493/abt-530 Glecaprevir/Pibrentasvir
Tablet
(Experimental)
Ombitasvir/paritaprevir/ritonavir in HCV GT1 infected participants for 12 weeks
ombitasvir/paritaprevir/ritonavir
Tablet
(Experimental)
ABT-493/ABT-530, in HCV GT1-GT6 infected participants for 12 weeks
abt-493/abt-530 Glecaprevir/Pibrentasvir
Tablet
(Experimental)
ABT-493/ABT-530 in renal impaired participants for 8 weeks
abt-493/abt-530 Glecaprevir/Pibrentasvir
Tablet

Primary Outcomes

Measure
Percentage of participants who achieve 12-week sustained virologic response (SVR12)
time frame: Up to 12 weeks after last dose of study drug

Secondary Outcomes

Measure
Percentage of participants treated with ABT-493/ABT-530 who achieve 12-week sustained virologic response (SVR12)
time frame: Up to 12 weeks after the last dose of study drug
Percentage of participants who achieve 12-week sustained virologic response (SVR12) for each sub-population
time frame: Up to 12 weeks after last dose of study drug
Percentage of participants with virologic failure during treatment
time frame: Up to last dose of study drug, minimally week 8
Percentage of participants 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: - Screening central laboratory result indicating HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype. - Chronic HCV infection defined as one of the following: - Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening. - A liver biopsy consistent with chronic HCV infection. - Must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures. - Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements. - Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI). Exclusion Criteria: - Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. - Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. - Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti human immunodeficiency virus antibody (HIV Ab). - Receipt of any investigational product within a time period equal to 10 half‑lives of the product, if known, or a minimum of 6 weeks (whichever is longer) prior to study drug administration. - Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Additional Information

Official title A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.