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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: adefovir dipivoxil (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official 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.'

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Normalization of ALT, and HBV-DNA <400 copies/mL

HBsAg quantitative loss and anti-HBs seroconversion

Secondary outcome: AEs, lab parameters, vital signs


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Ankara 06018, Turkey

Ankara 06100, Turkey

Ankara 06500, Turkey

Ankara 06800, Turkey

Gaziantep 27310, Turkey

Additional Information

Starting date: August 2008
Last updated: August 17, 2015

Page last updated: August 23, 2015

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