An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)

Hoffmann-La Roche107 enrolled

Overview

This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.

Study Type

OBSERVATIONAL

Enrollment

107

Conditions

Hepatitis B, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/=18 years of age * Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis Exclusion Criteria: * Co-infection with hepatitis A, C or D * Co-infection with human immunodeficiency virus (HIV) * Severe hepatic dysfunction or decompensated liver disease

Locations (16)

Unnamed facility

Alexandroupoli, Greece

Unnamed facility

Athens, Greece

Unnamed facility

Athens, Greece

Unnamed facility

Outcomes

Primary Outcomes

Percentage of patients with combined (virological and biochemical) response

Time frame: 48 weeks after end of treatment

Secondary Outcomes

Normalization of serum alanine aminotransferase

Time frame: 12 months

Safety (Incidence of adverse events)

Time frame: 12 months

Data from ClinicalTrials.gov

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