Overview

This trial has been completed.

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 February 2017
Trial size 694 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
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
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

All 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 February 2017.
Information provided to ClinicalTrials.gov by AbbVie.