Status:
WITHDRAWN
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with Hbe...
Eligibility Criteria
Inclusion
- adult patients, \>/= 18 years of age
- chronic hepatitis B for \>/= 6 months
- HBeAg negative at screening
- adequate renal function
Exclusion
- antiviral therapy for chronic hepatitis B within the previous 6 months
- hepatitis A, C, D or HIV infection
- treatment with systemic acyclovir or famciclovir within the previous 6 months
- decompensated liver disease (Childs B-C)
- history or evidence of a medical condition associated with chronic liver disease
Key Trial Info
Start Date :
September 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01179594
Start Date
September 18 2010
End Date
November 1 2014
Last Update
February 17 2017
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