Response and markers of response in chronic hepatitis B patients treated with Peg-interferon alfa-2a and adefovir.
Recruiting
- Conditions
- All patients will receive PEGASYS® 180 microgram, administered sc once per week for 48 weeks and stopped thereafter. The dose of ADF dipivoxil (HEPSERA®) will be 10 mg daily for 48 weeks and stopped thereafter.
- Registration Number
- NL-OMON24114
- Lead Sponsor
- Roche PahrmaceuticalsGiliad UCB
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Male and female patients > 18 years of age;
2. Positive HBsAg for more than 6 months;
Exclusion Criteria
1. Patients co-infected with HCV, HDV, HIV or who have decompensated liver disease, hepato-cellular carcinoma, pre-existing severe depression or other psychiatric disease, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy will be excluded;
2. Patients who have received LAM therapy for their chronic hepatitis B within 6 weeks before enrollment or any other antiviral therapy for their chronic hepatitis B within 6 months before enrollment (e.g. INF);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method