Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Status: No longer recruiting
Protocol number: ML18253
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of 2 different treatment durations of PEGASYS with or without lamivudine on ALT and HBV DNA levels/correction in patients with HBeAg-negative chronic hepatitis B infection
Brief summary: This study will compare the efficacy and safety of 2 different durations of treatment with PEGASYS, in patients with HBeAg-negative chronic HBV. It will also compare PEGASYS treatment alone and in combination with lamivudine. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is 250.
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, end of follow-up, and 24 weeks' follow-up
Safety: AEs, vital signs, lab values
Inclusion criteria:
- adult patients 18-70 years of age;
- HBeAg-negative chronic hepatitis B for >=6 months;
- liver disease consistent with chronic hepatitis B.
Exclusion criteria:
- interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory therapy <=12 months before first dose of study drug;
- nonresponders to previous interferon therapy;
- co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
- hepatocellular cancer;
- compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: February, 2005
Trial registration date: 10/28/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Bologna
- Brescia
- Cagliari
- Caserta
- Castellana Grotte
- Messina
- Milano
- Napoli
- Padova
- Palermo
- Parma
- Pisa
- San Giovanni Rotondo
- Torino
- Udine
- Verona
