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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00661076

Purpose

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: peginterferon alfa-2a (40KD) [PEGASYS] Drug: adefovir dipivoxil	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines Adefovir dipivoxil Adefovir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.'

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 ]

Estimated Enrollment:	72
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2013

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms weekly for 48 weeks Drug: adefovir dipivoxil 10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms weekly for 48 weeks Drug: adefovir dipivoxil 10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
3: Active Comparator	Drug: peginterferon alfa-2a (40KD) [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

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

Contacts

Contact: Please reference Study ID Number: ML20622	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Turkey
	Recruiting
ANKARA, Turkey, 06100
	Not yet recruiting
ANKARA, Turkey, 06100
	Recruiting
GAZIANTEP, Turkey, 27310
	Recruiting
ANKARA, Turkey, 06500
	Recruiting
ANKARA, Turkey, 06018

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20622
Study First Received:	April 16, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00661076
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases

Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
DNA Virus Infections
Adefovir dipivoxil
Interferon Alfa-2a
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009