Chronic Hepatitis B, Liver Cirrhosis
Conditions
Brief summary
An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.
Interventions
OTHERBlood Sample Collection
Blood Sample Collection before and after the administration of I.V. Hepabig Inj. on LT day(0 day); 1 day after; 1, 4, 12 and 24 weeks after LT.
Sponsors
Green Cross Corporation
Dong-Gu Kim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≤18 years old * Patients who understand the informed consent form and signed the form voluntarily * Patients who underwent liver transplantation due to HBV related disease and will be treated for prevention of hepatitis B relapse after liver transplantation
Exclusion criteria
* Multi-organ recipient or reimplantation * IgA Deficiency * Serious nephropathy * Serious cardiovascular system failure within 6 months * Ischemic or hemolytic anemia * Condition of immunosuppression and immunodeficiency * Hypersensitivity or allergic to blood products * HIV or HCV positive * Participation to other clinical trial within 3 months * Pregnancy or breast feeding * Those who the investigator determines inappropriate to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti-HBs titer | up to 6 months | The anti-HBs titer is measured on the day of LT, day 1, week 1, week 4, week 12 and week 24, to determine the pharmacokinetic characteristic of Hepabig I.V. injection |
Countries
South Korea
Outcome results
None listed