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
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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UNKNOWN
PHASE4
253 participants
INTERVENTIONAL
2015-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peginterferon alfa-2a
Peginterferon alfa-2a
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Yonsei University
OTHER
Responsible Party
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Sang Hoon Ahn
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML29378
Identifier Type: -
Identifier Source: org_study_id
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