A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 in people with HCV. ''Experimental'' means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C Infection.MedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005740-95-IT
- Lead Sponsor
- ABBOTT GMBH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Male or female between the age of 18 and 70 years, inclusive, at time of randomization. 2.Subject must have documentation that they meet one of the following categories: •Null-responders: received at least 12 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 reduction in HCV RNA at Week 12. Subjects will be considered to meet this definition if the lack of treatment response was documented following 10 to 16 weeks of treatment; •Non-responders/partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved = 2 log10 reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable at the end of treatment. Subjects will be considered to meet this definition if the lack of treatment response was documented following 10 to 16 weeks of treatment; or • Relapsers: received at least 36 weeks of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up. 3.Body mass index (BMI) is = 18 to < 38 kg/m2. Body mass index is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m). 4.Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment. Chronic HCV infection is defined as one of the following: •Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening; or •Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease). 5.Subject has a plasma HCV RNA level > 10,000 International Units (IU)/mL at screening.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
1.History of severe, life-threatening or other significant sensitivity to any drug. 2.Females who are pregnant or breastfeeding or males whose partner is pregnant or is planning to become pregnant within 6 months (or 7 months if required by local RBV label) after their last dose of study drug/RBV. 3.Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol. 4.Positive test result for hepatitis B surface antigen (HBsAg) or anti-HIV antibodies (anti-HIV Ab). 5.Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy showing cirrhosis or bridging fibrosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are to evaluate the safety of both arms and to compare the efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, {HCV RNA < LLOQ 12 weeks following therapy}) with 3 DAAs with and without RBV.;Secondary Objective: - To compare the percentage of subjects achieving SVR24 (HCV RNA < LLOQ 24 weeks following therapy), rapid virologic response (RVR, HCV RNA < LLOQ at Week 4), and end of treatment response (EOTR, HCV RNA < LLOQ at Week 12) following 3 DAA/RBV/12 versus 3 DAA/12. - To compare the antiviral activity (SVR12, SVR24, RVR, EOTR) of the treatment regimens within the pegIFN/RBV treatment null-responder, non-responder/partial responder and relapser populations.;Primary end point(s): The primary efficacy endpoint is the percentage of all subjects with SVR12.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. The percentage of subjects with SVR24, RVR, and EOTR; 2. The percentage of subjects within each population (null-responders, non responders/partial responders, and relapsers) with SVR12, SVR24, RVR, and EOTR.;Timepoint(s) of evaluation of this end point: 24 weeks after last dose of study drug.