A multicenter, randomized, controlled study comparing the efficacy and safety of 48 weeks of 40kD branched pegylated interferon alfa-2a (PEGASYS, Ro 25-8310) versus 96 weeks of PEGASYS, alone or in combination with 100 mg lamivudine for 48 weeks in patients with HBeAg-negative chronic hepatitis B.
- Conditions
- Treatment of chronic hepatitis B, HBeAg-negativeMedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2004-002985-39-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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) no
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 Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method