Status:
COMPLETED
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Hepatitis B
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- HBsAg Positive candidate for HBV-related liver transplant
- Primary, single organ recipients
- written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01513850
Start Date
October 1 2010
End Date
March 1 2014
Last Update
June 1 2015
Active Locations (1)
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1
SKChemicals
Seongnam, Gyunggi-do, South Korea