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

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01283074
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

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Exclusion Criteria

• Co-infection with hepatitis A, C or D
• Co-infection with human immunodeficiency virus (HIV)
• Severe hepatic dysfunction or decompensated liver disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with combined (virological and biochemical) response	48 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Normalization of serum alanine aminotransferase	12 months
Safety (Incidence of adverse events)	12 months