Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation

Dong-Gu Kim20 enrolled

Overview

An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Cirrhosis Chronic Hepatitis B

Interventions

Blood Sample CollectionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University, Seoul St Mary Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

anti-HBs titer

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

Time frame: up to 6 months

Data from ClinicalTrials.gov

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