Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

NCT ID: NCT02822547

Last Updated: 2016-07-04

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peginterferon alfa-2a

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

Patients will receive Peginterferon alfa-2a according to the standard medical practice

Interventions

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Peginterferon alfa-2a

Patients will receive Peginterferon alfa-2a according to the standard medical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of HBsAg positive for more than 6 months
* HBeAg-positive or HBeAg-negative within 8 weeks
* Serum AST or ALT ≥ 80 IU/L
* HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10\^5 copies/mL (or 20,000 IU/mL)
* HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10\^4 copies/mL(or 2,000 IU/mL)

Exclusion Criteria

* History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
* Prior treatment of interferon
* Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
* Other chronic liver disease or decompensated liver disease
* platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3
* Pregnant or lactating woman
* History of Organ transplantation
* Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Sang Hoon Ahn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Hoon Ahn

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Hoon Ahn

Role: CONTACT

82-2-2228-1936

Facility Contacts

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Sang Hoon Ahn, M.D.Ph.D

Role: primary

+82-11-419-8087

Jun Yong Park, M.D

Role: backup

+82-10-8353-0670

Other Identifiers

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ML29378

Identifier Type: -

Identifier Source: org_study_id

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