A study to evaluate the safety and efficacy of ombitasvir/ABT-450/ritonavir with sofosbuvir with or without ribavirin in adults with Chronic Hepatitis C Virus infection.
- Conditions
- Chronic Hepatitis C Virus (HCV) InfectionMedDRA version: 20.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-003147-35-GB
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
1. Chronic HCV infection prior to study enrollment.
2. Screening laboratory results from the central clinical laboratory indicating either HCV genotype 2 or 3 infection only (no mixed genotype).
3. Absence OR presence of cirrhosis.
4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC).
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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
3. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267), simeprevir, ledipasvir and daclatasvir. 4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
5. Abnormal lab tests.
6. Females who are pregnant or plan to become pregnant or
breastfeeding, or males whose partners are pregnant or planning to
become pregnant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Percentage of subjects with sustained virologic response 12 weeks post-treatment.;<br> Secondary Objective: 1. Percentage of subjects with on-treatment virologic failure in each treatment arm<br> 2. Percentage of subjects with virologic relapse after treatment in each treatment arm<br> ;Primary end point(s): Percentage of subjects with sustained virologic response 12 weeks post-treatment.;Timepoint(s) of evaluation of this end point: 12 weeks after the last dose of active drug.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. Percentage of subjects with on-treatment virologic failure in each treatment arm<br> 2. Percentage of subjects with virologic relapse after treatment in each treatment arm<br> ;<br> Timepoint(s) of evaluation of this end point: - All visits from 6 weeks after first dose (for 12-week and 8-week<br> treatment) or at least 26 days of treatment (6 week treatment) to 6, 8,<br> or 12 weeks after first dose<br><br> - 12 weeks after the last actual dose of active study drug<br>