ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00661076
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 adefovir dipivoxil - 1 peginterferon alfa-2a [Pegasys] - 2 peginterferon alfa-2a [Pegasys] - 3 peginterferon alfa-2a [Pegasys] - 2 adefovir dipivoxil -
- Primary Outcome Measures
Name Time Method Normalization of ALT, and HBV-DNA <400 copies/mL Week 96 for arm 1; week 48 for arms 2 and 3 HBsAg quantitative loss and anti-HBs seroconversion Weeks 48, 96 and 144
- Secondary Outcome Measures
Name Time Method AEs, lab parameters, vital signs Throughtout study