NCT01283074
Completed
N/A
Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)
ConditionsHepatitis B, Chronic
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 107
- Primary Endpoint
- Percentage of patients with combined (virological and biochemical) response
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
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(12 months)
- Safety (Incidence of adverse events)(12 months)
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