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

Dong-Gu Kim

Status: Completed

Conditions: Liver Cirrhosis; Chronic Hepatitis B

Treatments: Other: Blood Sample Collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02125071

I.V. Hepabig injection_IIT

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Hepabig

Description:

Those who receiving I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation

Treatment:

Other: Blood Sample Collection