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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661076
First received: April 16, 2008
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This 3 arm study will compare the efficacy and safety of combination therapy wit h PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negati ve 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 siz e 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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • HBsAg quantitative loss and anti-HBs seroconversion [ Time Frame: Weeks 48, 96 and 144 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs, lab parameters, vital signs [ Time Frame: Throughtout study ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661076

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00661076     History of Changes
Other Study ID Numbers: ML20622
Study First Received: April 16, 2008
Last Updated: November 3, 2014
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014