A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic HCV Who Failed a Prior DAA Containing Therapy

Phase 1

Active, not recruiting

• Conditions: Hepatitis C Virus (HCV); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002350-13-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-20
• Study Completion: 2017-01-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 141

Inclusion Criteria

1.Previous treatment with DAA-containing regimen for chronic HCV, genotype 1 (Part 1 and 2) or chronic HCV genotype 4, 5, 6 (Part 2) -infection resulting in either on-treatment virologic failure or post-treatment relapse
2.Chronic HCV GT1-infection in Part 1 or HCV GT 1 or 4-6 in Part 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this study are to assess the efficacy and safety of ABT-493 and ABT-530 (or ABT-493/ABT-530 in Part 2) with and without ribavirin (RBV; in Part 1) in DAA treatment-experienced non-cirrhotic or cirrhotic (Part 2) adults with chronic HCV infection.;Secondary Objective: Secondary objectives are to characterize the pharmacokinetics of DAAs including ABT-493, ABT-530, and RBV (if applicable), and to evaluate the contribution of RBV in Part 1.;Primary end point(s): The primary efficacy variable is SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).;Timepoint(s) of evaluation of this end point: 12 weeks following last dose of study drug

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): SVR4 (HCV RNA < LLOQ 4 weeks after the last actual dose of study drug);<br> On-treatment virologic failure;<br> Post-treatment relapse<br> ;Timepoint(s) of evaluation of this end point: 4 weeks following last subject last dose of study drug