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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 16, 2008
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: adefovir dipivoxil
Drug: peginterferon alfa-2a [Pegasys]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.'

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Normalization of ALT, and HBV-DNA <400 copies/mL [ Time Frame: Week 96 for arm 1; week 48 for arms 2 and 3 ]
  • HBsAg quantitative loss and anti-HBs seroconversion [ Time Frame: Weeks 48, 96 and 144 ]

Secondary Outcome Measures:
  • AEs, lab parameters, vital signs [ Time Frame: Throughtout study ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: adefovir dipivoxil
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks
Experimental: 2 Drug: adefovir dipivoxil
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks
Active Comparator: 3 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00661076

Ankara, Turkey, 06018
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Ankara, Turkey, 06800
Gaziantep, Turkey, 27310
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00661076     History of Changes
Other Study ID Numbers: ML20622
Study First Received: April 16, 2008
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents processed this record on May 24, 2017