NCT00962871

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	360 micrograms sc/week for 2 weeks
DRUG	tenofovir	300mg po daily for 2 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-08-20
• Last updated: 2016-02-08
• Results posted: 2016-01-13

Locations

6 sites across 4 countries: United States, New Zealand, Singapore, Taiwan