Conditions: Hepatitis B Liver Transplantation
Keywords: Hepatitis B HBV Orthotopic liver transplantation Liver transplantation Recurrence Reinfection Protective titers HBsAb Hepatitis B virus immune globulin Niuliva
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six and twelve months post-transplantation.

Detailed description:

Arms:
arm 1: Treatment group (newly liver transplanted subjects due to HBV induced liver disease)

Interventions: intervention 1: Hepatitis B immune globulin
Intervention descriptions: intervention 1: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.

Protocol document: