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

Roche

Status and phase: Completed; Phase 1

Conditions: Hepatitis B, Chronic

Treatments: Drug: tenofovir; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962871

PP22512

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

1

Active Comparator group

Treatment:

Drug: tenofovir

2

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: tenofovir

3

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

4

No Intervention group