Back to resultsA Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hepabulin IV
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Liver Transplantation, HBV, HBV Recurrence, HBsAg Positive
Eligibility Criteria
Inclusion Criteria:
- HBsAg Positive candidate for HBV-related liver transplant
- Primary, single organ recipients
- written informed consent
Exclusion Criteria:
- acute renal failure, Serum creatinin >1.5*ULN
- severe cardiac disease or other significant disease
- HAV, HCV or HIV positive
- Immunoglobulin A deficiency.
- History of hypersensitivity to Human Immunoglobulin.
- History of cancer within 5 years. (without HCC)
- History of alcohol or/and drug abuse.
- History organ transplantation.
- Within 30 days, participation in another clinical trial and use of an investigational product.
- Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Sites / Locations
- SKChemicals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hepabulin IV
Arm Description
Outcomes
Primary Outcome Measures
HBV(HBsAg) recurrence
Secondary Outcome Measures
Time to recurrence
Survival
viral Marker of HBV
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01513850
Brief Title
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Official Title
A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
Detailed Description
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Liver Transplantation, HBV, HBV Recurrence, HBsAg Positive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hepabulin IV
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hepabulin IV
Intervention Description
I.V.
Primary Outcome Measure Information:
Title
HBV(HBsAg) recurrence
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to recurrence
Time Frame
52 weeks
Title
Survival
Time Frame
52 weeks
Title
viral Marker of HBV
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HBsAg Positive candidate for HBV-related liver transplant
Primary, single organ recipients
written informed consent
Exclusion Criteria:
acute renal failure, Serum creatinin >1.5*ULN
severe cardiac disease or other significant disease
HAV, HCV or HIV positive
Immunoglobulin A deficiency.
History of hypersensitivity to Human Immunoglobulin.
History of cancer within 5 years. (without HCC)
History of alcohol or/and drug abuse.
History organ transplantation.
Within 30 days, participation in another clinical trial and use of an investigational product.
Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Goo Kim, MD, PhD
Organizational Affiliation
St.Mary's Hospital, Catholic University Medical college
Official's Role
Study Chair
Facility Information:
Facility Name
SKChemicals
City
Seongnam
State/Province
Gyunggi-do
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
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