Trial information
A Study of PEGASYS (Peginterferon alfa-2a(40KD)) in Patients With Chronic Hepatitis B Virus (HBV)
Status: No longer recruiting
Protocol number: ML18286
Sponsor: Roche Hellas SA
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of 2 different treatment durations of PEGASYS on ALT normalization in treatment-naïve patients with chronic hepatitis B infection
Brief summary: This study will compare the efficacy and safety of 2 different treatment periods of PEGASYS in treatment-naive patients with chronic HBV. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is
200.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Alanine aminotransferase normalization plus lowering of HBV-DNA levels to <20,000 copies/mL at end of follow-up period
Key secondary outcomes: 1. Efficacy:ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL,HBV-DNA below limit of quantification,and HBsAg loss and anti-HBs seroconversion at EoT and at 24 weeks' follow-up.
Safety:Adverse events,vital signs,laboratory values
Inclusion criteria:
- adult patients 18-70 years of age;
- HBeAg-negative chronic HBV for >=6 months;
- liver biopsy obtained within past 24 months showing chronic HBV;
- treatment naive.
Exclusion criteria:
- co-infection with hepatitis A, C, or D virus, or with human immunodeficiency virus (HIV);
- anti-hepatitis B, anti-viral, anti-neoplastic, or immunomodulatory therapy <=12 months before study;
- hepatocellular cancer;
- serious concomitant diseases of the cardiovascular, respiratory or CNS system.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: April, 2005
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Greece
- Aigaleo - Attiki
- Alexandroupolis
- Athens
- Piraeus
