Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus
Treatments abt-493, abt-530, ribavirin (rbv), abt-493/abt-530
Phase phase 2
Sponsor AbbVie
Start date September 2014
End date January 2017
Trial size 725 participants
Trial identifier NCT02243293, 2014-002927-90, M14-868

Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV genotypes 2, 3, 4, 5 or 6 infection.

In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naive subjects without cirrhosis.

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 Dose A + ABT-530 Dose A for 12 weeks in HCV genotype 2 (GT2) -infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A for 12 weeks in HCV GT2-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A coadministered with ribavirin (RBV) for 12 weeks in HCV GT2-infected subjects
abt-493
Tablet
abt-530
Tablet
ribavirin (rbv)
Tablet
(Experimental)
ABT-493 Dose A + ABT-530 Dose A for 12 weeks in HCV genotype 3 (GT3) -infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A for 12 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A coadministered with ribavirin (RBV) for 12 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
ribavirin (rbv)
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose B for 12 weeks in HCV GT3-infected subjects.
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A for 8 weeks in HCV GT2-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose B for 8 weeks in HCV GT2-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose A + ABT-530 Dose A for 8 weeks in HCV GT2-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose A for 8 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose A + ABT-530 Dose A for 8 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose C for 12 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose B + ABT-530 Dose C + RBV for 12 weeks in HCV GT3-infected subjects
abt-493
Tablet
abt-530
Tablet
ribavirin (rbv)
Tablet
(Experimental)
ABT-493 Dose A + ABT-530 Dose A for 12 weeks in HCV GT3 cirrhotic subjects
abt-493
Tablet
abt-530
Tablet
(Experimental)
ABT-493 Dose A + ABT-530 Dose A + RBV for 12 weeks in HCV GT3 cirrhotic subjects
abt-493
Tablet
abt-530
Tablet
ribavirin (rbv)
Tablet
(Experimental)
ABT-493/ABT-530 in HCV GT3-infected subjects for 12 weeks
abt-493/abt-530
Tablet
(Experimental)
ABT-493/ABT-530 in HCV GT3-infected subjects for 16 weeks
abt-493/abt-530
Tablet
(Experimental)
ABT-493/ABT-530 in HCV GT2, 4, 5, or 6-infected subjects for 8 weeks
abt-493/abt-530
Tablet

Primary Outcomes

Measure
Percentage of subjects who achieve 12-week sustained virologic response (SVR12) in each treatment arm
time frame: 12 weeks after last dose of study drug
Percentage of genotype 2 (GT2) subjects, in Part 4, treated with ABT-493/ABT-530 who achieve sustain virologic response 12 weeks after treatment (SVR12): Non-inferiority to historical control
time frame: 12 weeks after the last dose of study drug

Secondary Outcomes

Measure
Percentage of subjects who achieve 4-week sustained virologic response (SVR4) in each treatment arm
time frame: 4 weeks after last dose of study drug
Percentage of subjects with virologic failure during treatment
time frame: Up to Treatment Week 12
Percentage of subjects with Post-Treatment relapse
time frame: 12 weeks after the last dose of study drug

Eligibility Criteria

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

Inclusion Criteria: - Male or female between at least 18 years of age at time of Screening - Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection. - Chronic HCV infection. - Subject must be either HCV treatment-naïve or treatment-experienced. - Subject must be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only). Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any drug. - 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). - HCV genotype performed during screening indicating co-infection with more than one HCV genotype.

Additional Information

Official title A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.