A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

Completed · Phase 1

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT00962871

Run by

Hoffmann-La Roche

People needed

30

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• male adults of Southeast and/or East Asian origin, 18-55 years of age
• HBeAg-positive chronic hepatitis B
• detectable HBV DNA

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Grafton, New Zealand
• Study site — Singapore, Singapore
• Study site — Singapore, Singapore
• Study site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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