Trial information
A Pilot Study of New-Onset Therapy With PEGASYS (Peginterferon alfa-2a (40KD)) in Pre-Treated Patients With Chronic Hepatitis B.
Status: Completed
Protocol number: ML17619
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomised, open-label study to compare the effect of new-onset therapy with PEGASYS, and continuation therapy with adefovir dipivoxil or lamivudine, on viral response in patients with chronic hepatitis B pre-treated with adefovir dipivoxil or lamivudine.
Brief summary: This study will compare the efficacy and safety of PEGASYS (180 micrograms sc weekly) and continued treatment with adefovir dipivoxil (10mg po, daily) or lamivudine (100mg po, daily) in patients with chronic hepatitis B (CHB) who have been pre-treated with adefovir dipivoxil or lamivudine for >6 months. Patients will be randomized to receive either PEGASYS for 48 weeks (first 4 weeks in addition to pre-existing adefovir dipivoxil or lamivudine) followed by a 24 week treatment-free period, or adefovir dipivoxil or lamivudine for 72 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is
140.
Study phase: IV
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. Loss of HBsAg at 72 weeks after start of randomized treatment.
Key secondary outcomes: 1. Efficacy: Loss of HBsAg at 48 weeks, HBV DNA BLQ at weeks 48 and 72, ALT at weeks 48 and 72. Safety: Adverse events, laboratory tests.
Inclusion criteria:
- adult patients, >=18 years of age;
- pre-treatment with adefovir dipivoxil or lamivudine for >6 months;
- HBsAg positive / HBeAg positive or negative with viral DNA < 10000 copies/mL.
Exclusion criteria:
- interferon-based treatment in past 6 months;
- coinfection with hepatitis C, hepatitis D or HIV;
- liver cirrhosis, decompensated liver disease, or hepato-cellular carcinoma.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
France
- Bondy
- Clermont-Ferrand
- Creteil
- Orleans
- Paris
- Saint Laurent Du Var
