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

Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01283074

Enrollment

107

Registered

2011-01-25

Start date

2009-05-31

Completion date

2012-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Normalization of serum alanine aminotransferase	12 months
Safety (Incidence of adverse events)	12 months

Countries

Greece

Outcome results