A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infectio

Phase 1

• Conditions: Chronic Hepatitis C Virus Genotype 4, 5 or 6 Infection; MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002349-80-IT
• Lead Sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-09
• Study Start: 2018-02-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 121

Inclusion Criteria

1. Male or female, at least 18 years of age at time of Screening.
2. Screening laboratory result indicating HCV GT4, 5, or 6 infection.
3. Chronic HCV infection.
4. Subject must be HCV DAA treatment-naïve.
5. Subjects are considered to be non-cirrhotic as per protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. 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.
2. 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.
3. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
4. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
5. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The percentages of subjects with on-treatment virologic failure. The percentage of subjects with post-treatment relapse.;Primary end point(s): SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).;Timepoint(s) of evaluation of this end point: 12 weeks after the last actual dose of study drug.;Main Objective: To assess the efficacy (SVR12) and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype (GT) 4, 5, or 6 infection without cirrhosis.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1.The percentage of subjects with on-treatment virologic failure.<br> 2. The percentage of subjects with post-treatment relapse.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. During treatment and at the end of treatment with at least 6 weeks of treatment.<br> 2. At the end of treatment and 12 weeks after the last dose of study drug (among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment).<br>