Status:
COMPLETED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or 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 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to ...
Eligibility Criteria
Inclusion
- adult patients, 18-65 years of age;
- HBeAg+ve for \>=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- \>=3 months treatment-free interval from nucleotide analogues.
Exclusion
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
Key Trial Info
Start Date :
May 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2014
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00922207
Start Date
May 7 2010
End Date
September 29 2014
Last Update
April 10 2017
Active Locations (9)
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1
Changhua Christian Hospital; Internal Medicine
Changhua, Taiwan, 500
2
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, Taiwan, 00833
3
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, Taiwan, 807
4
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung, Taiwan, 204