Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults
Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.
1 other identifier
interventional
253
1 country
1
Brief Summary
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 4, 2016
June 1, 2016
1.5 years
June 30, 2016
June 30, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
12 week from baseline
The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB
12 week from baseline
Secondary Outcomes (4)
The change of HBV DNA at Week 12 from baseline
12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline
4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline
4, 8, 12 week from baseline
The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12
12 week from baseline
Study Arms (1)
Peginterferon alfa-2a
EXPERIMENTALInterventions
Patients will receive Peginterferon alfa-2a according to the standard medical practice
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- Roche Pharma AGcollaborator
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Hoon Ahn
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 4, 2016
Study Start
March 1, 2015
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
July 4, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share