Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies

Phase 1

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

• Registration Number: EUCTR2016-002491-26-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-12
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female subjects must be adults (18 years or more) or adolescents (12 to less than 18 years). Adolescent subjects must weigh at least 35 kg.
2. Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
3. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
4. Cirrhotic Subjects must have compensated cirrhosis, (Child-Pugh score of = 6) at screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
5. Cirrhotic Subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.
Are the trial subjects under 18? yes
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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
2. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
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, and failure in an AbbVie HCV parent study due to non-virologic reasons.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
5. Screening laboratory analyses showing calculated creatinine clearance < 30 mL/min.
6. Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
7. Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

Study & Design

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