Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Status: Terminated
Protocol number: ML20135
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the effect of PEGASYS on ALT and HBV DNA levels in patients with lamivudine-resistant HbeAg-negative chronic hepatitis B
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. Target sample size is 60.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Normalization of ALT, and HBV-DNA <10,000 copies/mL Time frame: Week 96
Key secondary outcomes: 1. Normalization of ALT, and HBV-DNA <10,000 copies/mL Time frame: Weeks 48 and 72
2. HBsAg loss and anti-HBs seroconversion Time frame: Weeks 48, 72 and 96
3. AEs and lab parameters Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 04/17/2007
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Turkey
- Ankara
- Antalya
- Istanbul
- Izmir
