At a glance
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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.
In Brief
A Phase 1 clinical trial evaluating peginterferon alfa-2a [Pegasys] and tenofovir for Hepatitis B, Chronic. Completed, enrolled 30 participants across 6 sites in 4 countries.
Detailed 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 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.
Study Details
Timeline
Interventions
360 micrograms sc/week for 2 weeks
300mg po daily for 2 weeks