A Phase III, Multicentre, Double Blinded Study in Patients with Chronic Hepatitis C who are Non-responders to prior PEGinterferon alpha + Ribavirin Therapy Comparing Treatment with Thymosin alpha 1 + PEGinterferon alfa-2a plus Ribavirin with PEGinterferon alfa-2a + Ribavirin + Placebo
- Conditions
- Treatment of Patients with Chronic Hepatitis C who are Non-responders to a course with approved doses of PEGinterferon alpha + RibavirinMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2004-001277-25-IT
- Lead Sponsor
- SIGMA-TA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
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