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.
Overview
- Phase
- Phase 1
- Intervention
- tenofovir
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 30
- Primary Endpoint
- Mean Change From Baseline in Viral Quantitative e Antibody
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
1
Intervention: tenofovir
2
Intervention: peginterferon alfa-2a [Pegasys]
2
Intervention: tenofovir
3
Intervention: peginterferon alfa-2a [Pegasys]
Outcomes
Primary Outcomes
Mean Change From Baseline in Viral Quantitative e Antibody
Time Frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
Secondary Outcomes
- Mean Change From Baseline in HBV-DNA log10(Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys))
- Early Changes in Viral Sequence Associated With Viral Suppression(Day 1, 5, 14, Week 4 and 6)