A 3-year follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response
- Conditions
- Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-006131-38-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
-Written informed consent must be obtained before any assessment is performed
-Males or females must be aged 18 years or older
-Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir
-Have achieved SVR24
-Are able to comply with visit schedule
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer
-Use or planned use to start a new course of hepatitis C therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method