Status:
COMPLETED
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00661076
Start Date
August 1 2008
End Date
May 1 2011
Last Update
November 2 2016
Active Locations (5)
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1
Ankara, Turkey (Türkiye), 06018
2
Ankara, Turkey (Türkiye), 06100
3
Ankara, Turkey (Türkiye), 06500
4
Ankara, Turkey (Türkiye), 06800