A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 in people with Hepatitis C Virus. Experimental means that they have not been approved by any regulatory agency for sale to the public.
- Conditions
- Chronic Hepatitis C InfectionMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-022455-31-ES
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
- Males and females 18-70 years old, inclusive
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.
- Chronic hepatitis C, genotype 1 infection
- Treatment naive OR prior null-responders to previous treatment with pegIFN and RBV
- No evidence of liver cirrhosis
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- Positive screen for drugs and alcohol
- Significant sensitivity to any drug
- Use of contraindicated or prohibited medications within 1 month of dosing
- Abnormal laboratory tests
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the safety of all treatment regimens and the percentage of subjects achieving 24-week sustained virologic response (SVR24) (HCV RNA < LLOD at post-treatment Week 24) following treatment with 3 DAAs and RBV in HCV genotype 1-infected treatment-naïve adults.;Secondary Objective: To compare the percentage of subjects achieving SVR24;<br>? following treatment with 3 DAAs with RBV in treatment naïve and null responder subjects<br>? following treatment with 2 DAAs with RBV versus 3 DAAs with RBV in treatment naïve subjects;Primary end point(s): The primary efficacy endpoint is the percentage of SVR24 in treatment naive subjects following treatment with 3 DAAs and RBV;Timepoint(s) of evaluation of this end point: 24 weeks after the last dose of study drug.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoints are comparison of the percentage of subjects with SVR24:<br>? following treatment with 3 DAAs with RBV in treatment naïve and null responder subjects<br>? following treatment with 2 DAAs with RBV versus 3 DAAs with RBV in treatment naïve subjects;Timepoint(s) of evaluation of this end point: 24 weeks after the last dose of study drug.