A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Phase 4
Terminated
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: peginterferon alfa-2a (40KD) [PEGASYS]
- Registration Number
- NCT00460850
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- adult patients, 18-65 years of age;
- HBeAg negative chronic hepatitis B;
- treated with lamivudine for >=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Exclusion Criteria
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with chronic liver disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 peginterferon alfa-2a (40KD) [PEGASYS] -
- Primary Outcome Measures
Name Time Method Normalization of ALT, and HBV-DNA <10,000 copies/mL Week 96
- Secondary Outcome Measures
Name Time Method Normalization of ALT, and HBV-DNA <10,000 copies/mL Weeks 48 and 72 HBsAg loss and anti-HBs seroconversion Weeks 48, 72 and 96 AEs and lab parameters Throughout study