ong-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C. - ND
- Conditions
- ong-term Follow-up of prior study participants.MedDRA version: 9.1 Level: LLT Classification code 10019641 Term: Hepatic cirrhosis
- Registration Number
- EUCTR2006-006529-25-IT
- Lead Sponsor
- SCHERING-PLOUGH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1954
Subject must be willing to give written informed consent and be able to adhere to the visit schedule. - Subjects must have received at least one dose of SCH 503034 plus peginterferon alfa-2b with or without ribavirin or peginterferon alfa-2b plus ribavirin in a previous SPRI Phase 2 or 3 clinical study in which SCH 503034 was administered.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Concurrent participation in any other clinical study for the treatment of chronic hepatitis C. - Retreatment with any anitviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuatio from, the SPRI Phase 2 or 3 clinical study in which the subject previously participated/ - Any condition which on the opinion of the Investigtaor would make the subject unsuitable for enrollment.
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