Trial information
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Status: Recruiting
Protocol number: ML20622
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the effect of combination treatment with PEGASYS + adefovir dipivoxil versus PEGASYS monotherapy on HBV-DNA and ALT levels in patients with HBeAg-negative, chronic hepatitis B.
Brief summary: This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is 72.
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. Normalization of ALT, and HBV-DNA <400 copies/mL Time frame: Week 96 for arm 1; week 48 for arms 2 and 3
2. HBsAg quantitative loss and anti-HBs seroconversion Time frame: Weeks 48, 96 and 144
Key secondary outcomes: 1. AEs, lab parameters, vital signs Time frame: Throughtout study
Inclusion criteria:
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
- either nucleoside analogue naive, or has not received IFN-a in the past 6 months.
Exclusion criteria:
- positive for hepatitis A, C, D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
- antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 04/15/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Turkey
