Status:
TERMINATED
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekl...
Eligibility Criteria
Inclusion
- adult patients, 18-65 years of age;
- HBeAg negative chronic hepatitis B;
- treated with lamivudine for \>=6 months;
- demonstrated lamivudine resistance;
- compensated liver disease.
Exclusion
- severe hepatic dysfunction;
- previous treatment with antivirals other than lamivudine;
- immunosuppressant treatment in past 6 months;
- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- medical condition associated with chronic liver disease.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00460850
Start Date
September 1 2007
End Date
June 1 2008
Last Update
June 30 2008
Active Locations (4)
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1
Ankara, Turkey (Türkiye), 06620
2
Antalya, Turkey (Türkiye), 07058
3
Istanbul, Turkey (Türkiye), 34390
4
Izmir, Turkey (Türkiye), 35360