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 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis.

Phase 1

• Conditions: Chronic Hepatitis C Infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003797-32-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Male or female, at least 18 years of age at time of Screening.
2. Screening laboratory result indicating HCV GT1, 2, 4, 5, or 6 infection.
3. Chronic HCV infection.
4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy. Prior HCV treatment with any other approved or investigational medications is not allowed.
5. Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease.
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

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

Study & Design

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