Chronic Hepatitis C Infection
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to assess the efficacy by evaluating the percentage of subjects achieving a 12-week post-treatment sustained virologic failure response (SVR12) in each treatment arm and safety of ABT-493/ABT-530 plus SOF and RBV in adults or adolescents with chronic HCV GT1-6 infection who previously failed HCV treatment in an AbbVie HCV clinical study, designated as an AbbVie HCV parent study. ;Secondary Objective: Secondary objectives are to assess the percentage of subjects with HCV on-treatment virologic failure, and the percentage of subjects with HCV virologic relapse. ;Primary end point(s): The primary efficacy endpoint is the percentage of subjects in the ITT population who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug), by treatment arm and overall. The number and percentage of subjects achieving SVR12 will be summarized along with a two-sided 95% confidence interval using the normal approximation to the binomial distribution, unless the number of virologic failures is less than 5, then the Wilson's score method will be used for the confidence interval instead. A summary of reason for SVR12 non-response (e.g., on-treatment virologic failure, relapse, other) will be provided. ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: • The percentage of subjects with on-treatment HCV virologic failure in each treatment arm and overall; • The percentage of subjects with post-treatment HCV virologic relapse in each treatment arm and overall. For the analysis of HCV virologic relapse, completion of treatment is defined as any subject with study drug duration of 77 days and 103 days or greater for subjects allocated to treatment durations of 12 weeks and 16 weeks, respectively. For each treatment arm and overall, as applicable, the number and percentage of subjects meeting each secondary efficacy endpoint will be summarized along with a two-sided 95% confidence interval using Wilson's score method. ;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment, and end of treatment to 24 weeks post treatment | — |
Countries
Australia, Canada, Germany, New Zealand, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd.
Outcome results
None listed