A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | February 2012 |
An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.
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 tenofovir or Pegasys plus tenofovir. Patients will be randomized
to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir
(300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment,
patients may opt to receive standard of care treatment with Pegasys. Target sample size is
<50.
in treatment-naïve Asian male patients with chronic hepatitis B after initiation of
treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized
to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir
(300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment,
patients may opt to receive standard of care treatment with Pegasys. Target sample size is
<50.
Inclusion Criteria:
- male adults of Southeast and/or East Asian origin, 18-55 years of age
- HBeAg-positive chronic hepatitis B
- detectable HBV DNA
Exclusion Criteria:
- 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 drug
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