Phase 1 N=30 Randomized Treatment

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

Hepatitis B, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00962871 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: Mean Change From Baseline in Viral Quantitative e Antibody — 0.07; 0.15; 0.02; 0.03 Cut-off index (C.O.I.)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: peginterferon alfa-2a [Pegasys] (Drug); tenofovir (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Hoffmann-La Roche
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Viral Quantitative e Antibody	0.07; 0.15; 0.02; 0.03; 0.00; 0.03	—
SECONDARY Mean Change From Baseline in HBV-DNA log10	-0.61; -0.46; -0.14; 0.08; -1.04; -0.75	—
SECONDARY Early Changes in Viral Sequence Associated With Viral Suppression	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00962871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.