ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B

Roche

Status and phase

Completed

Phase 3

Conditions

Hepatitis B, Chronic

Treatments

Drug: adefovir dipivoxil

Drug: peginterferon alfa-2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00661076

ML20622

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.