Status:
UNKNOWN
Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
Lead Sponsor:
Hanyang University
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B. * Increased HBeAg ser...
Eligibility Criteria
Inclusion
- Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA \> 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.
Exclusion
- Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT01220596
Start Date
June 1 2010
End Date
June 1 2013
Last Update
July 4 2011
Active Locations (20)
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1
Dong-A University Medical Center
Busan, Busan, South Korea, 602-103
2
Kosin University Gospel Hospital
Busan, Busan, South Korea, 602-702
3
Inje University Haeundae Paik Hospital
Busan, Busan, South Korea, 612-030
4
Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea, 330-715