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

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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.


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
We found this trial at
3
sites
681
mi
from 98109
San Francisco, CA
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7474
mi
from 98109
Grafton,
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962
mi
from 98109
Los Angeles, CA
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