Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB).
Status: Recruiting
Protocol number: ML20601
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study evaluating safety and the effect of PEGASYS® on HBV DNA levels in patients with HBeAg-positive and HBeAg-negative chronic hepatitis B
Brief summary: This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. once weekly. Following 48 weeks of treatment, there will be a 24 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
50.
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. Number of patients with HBV DNA <100,000 copies/mL Time frame: Week 72
Key secondary outcomes: 1. HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion. Time frame: Weeks 48 and 72
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-70 years of age;
- HBeAg positive, HBsAg positive for >=6 months;
- anti-HBs negative;
- HBV DNA >500,000 copies/mL.
Exclusion criteria:
- previous antiviral or interferon-based therapy for CHB;
- evidence of decompensated liver disease;
- chronic liver disease other than viral hepatitis;
- co-infection with active hepatitis A, C or D virus;
- co-infection with human immunodeficiency virus (HIV).
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 02/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Estonia
Latvia
Lithuania
