Status:
COMPLETED
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or...
Eligibility Criteria
Inclusion
- male adults of Southeast and/or East Asian origin, 18-55 years of age
- HBeAg-positive chronic hepatitis B
- detectable HBV DNA
Exclusion
- prior antiviral therapy for chronic hepatitis B
- evidence of bridging fibrosis, cirrhosis or decompensated liver disease
- positive test at screening for HAV (IgM), HCV, HDV or HIV
- history or evidence of medical condition associated with chronic liver disease
- antineoplastic or immunomodulatory treatment \</=6 months prior to first dose of study drug
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00962871
Start Date
August 1 2009
End Date
February 1 2012
Last Update
February 8 2016
Active Locations (6)
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1
Los Angeles, California, United States, 90036
2
San Francisco, California, United States, 94143-0538
3
Grafton, New Zealand, 1010
4
Singapore, Singapore, 119228