Hepatitis B
Conditions
Keywords
Liver Transplantation, HBV, HBV Recurrence, HBsAg Positive
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
Interventions
DRUGHepabulin IV
I.V.
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV(HBsAg) recurrence | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to recurrence | 52 weeks |
| Survival | 52 weeks |
| viral Marker of HBV | 52 weeks |
Countries
South Korea
Outcome results
None listed