Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive 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 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to rece...
Eligibility Criteria
Inclusion
- adult patients, 18-65 years of age;
- HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
- absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion
- previous treatment for chronic hepatitis B within previous 6 months;
- antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
- co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00614471
Start Date
August 1 2007
End Date
October 1 2009
Last Update
November 2 2016
Active Locations (8)
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1
Beijing, China, 100011
2
Hangzhou, China, 310003
3
Shanghai, China, 200021
4
Shanghai, China, 200025