CompletedPhase 1

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

United States, New Zealand, Singapore30 participantsStarted 2009-08

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \</=6 months prior to first dose of study drug

What they're measuring

Mean Change From Baseline in Viral Quantitative e Antibody

Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

Trial details

NCT IDNCT00962871

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2015-12-09

View on ClinicalTrials.gov More Hepatitis B, Chronic trials