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

NCT ID: NCT01283074

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Alexandroupoli, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Larissa, , Greece

Site Status

Pátrai, , Greece

Site Status

Piraeus, , Greece

Site Status

Piraeus, , Greece

Site Status

Rhodes, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Goulis I, Karatapanis S, Akriviadis E, Deutsch M, Dalekos GN, Raptopoulou-Gigi M, Mimidis K, Germanidis G, Drakoulis C, Triantos C, Zintzaras E, Bakalos G, Papatheodoridis G. On-treatment prediction of sustained response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B patients. Liver Int. 2015 May;35(5):1540-8. doi: 10.1111/liv.12725. Epub 2014 Nov 20.

Reference Type DERIVED
PMID: 25368957 (View on PubMed)

Other Identifiers

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ML22016

Identifier Type: -

Identifier Source: org_study_id