Status:
COMPLETED
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretre...
Eligibility Criteria
Inclusion
- Adult patients, \>=18 and \</= 65 years of age
- HBeAg positive chronic hepatitis B
- Pre-treatment with entecavir for 9-36 months
Exclusion
- Antiviral, antineoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, C or D, or HIV
- Evidence of decompensated liver disease
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00940485
Start Date
April 1 2009
End Date
December 1 2011
Last Update
March 25 2016
Active Locations (7)
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1
Changsha, China, 410008
2
Chengdu, China, 610041
3
Fuzhou, China, 350005
4
Guangzhou, China, 510515