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
Summary
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/mLHBsAg quantitative loss and anti-HBs seroconversion
Secondary outcome: AEs, lab parameters, vital signs
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
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
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