Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c virus, hepatitis c virus
Treatments abt-493/abt-530, sofosbuvir, ribavirin
Phase phase 3
Sponsor AbbVie
Start date April 2016
End date January 2017
Trial size 120 participants
Trial identifier NCT02723084, M15-828

Summary

The purpose of this study is to evaluate the efficacy and safety of 8 weeks of treatment with the combination regimen ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus Genotype 2 (GT2) infected participants.

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 GT2 infected participants without cirrhosis for 8 weeks
abt-493/abt-530
Tablet
(Active Comparator)
sofosbuvir plus ribavirin in HCV GT2 infected participants without cirrhosis for 12 weeks
sofosbuvir
Tablet
ribavirin
Capsule

Primary Outcomes

Measure
Percentage of participants who achieve 12-week sustained virologic response (SVR12) (non-inferiority analysis)
time frame: 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: 12 weeks after the last dose of study drug
Percentage of participants with on-treatment virologic failure
time frame: Up to 12 weeks while on treatment
Percentage of participants with Post-Treatment relapse
time frame: Up to 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 GT-2 infection without co-infection of any other genotype. - Subject has positive anti-HCV Ab and plasma HCV RNA viral load greater than or equal to 1000 IU/mL at Screening Visit. - 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; or - A liver biopsy consistent with chronic HCV infection. - Subject must be HCV Direct-acting antiviral agent (DAA) treatment-naïve (i.e., patient has not received a single dose of any approved or investigational DAA). Prior HCV treatment using IFNs with or without ribavirin is acceptable. Previous HCV Interferon (IFN) based treatment must have been completed greater than or equal to 2 months prior to screening. Exclusion Criteria: - 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). - Requirement for and inability to safely discontinue contraindicated medications or supplements at least 2 weeks or 10 half-lives (whichever is longer) prior to the first dose of any study drug. - Clinically significant abnormalities, other than HCV-infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to: - Uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin A1C) level > 8.5% at the Screening Visit. - Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years, or any history of HCC. - Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection. - 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, or steatohepatitis considered to be the primary cause of the liver disease rather than concomitant/incidental with HCV infection.

Additional Information

Official title A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.