Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, hepatitis c virus, hcv
Treatments abt-493, abt-530, ribavirin, abt-493/abt-530
Phase phase 2
Sponsor AbbVie
Start date April 2015
End date December 2016
Trial size 130 participants
Trial identifier NCT02446717, 2015-002350-13, M15-410

Summary

The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

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
abt-493
Tablets
abt-530
Tablets
(Experimental)
ABT-493 (Dose B) + ABT-530 (Dose B)+ RBV for 12 weeks
abt-493
Tablets
abt-530
Tablets
ribavirin
Tablets
(Experimental)
ABT-493 (Dose B) + ABT-530 (Dose B) for 12 weeks
abt-493
Tablets
abt-530
Tablets
(Experimental)
ABT-493/ABT-530 for 12 weeks
abt-493/abt-530
Tablets
(Experimental)
ABT-493/ABT-530 for 16 weeks
abt-493/abt-530
Tablets

Primary Outcomes

Measure
Percentage of participants with sustained virologic response (SVR) 12
time frame: 12 weeks after last dose of study drug

Secondary Outcomes

Measure
Percentage of participants with sustained virologic response (SVR) 4
time frame: 4 weeks after last dose of study drug
Percentage of participants with virologic failure during treatment
time frame: Tested minimally every 2 weeks up to last dose of study drug
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 70 years old.

Inclusion Criteria: 1. Previous treatment with DAA-containing regimen for chronic HCV infection resulting in either on-treatment virologic failure or post-treatment relapse 2. Chronic HCV GT 1, 4, 5, or 6-infection Exclusion Criteria: 1. History of severe, life-threatening or other significant sensitivity to any drug 2. 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 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol 4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) 5. 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 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.