NCT01131065

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B
• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Hepatitis B immune globulin	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.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-05-26
• Last updated: 2016-02-25
• Results posted: 2016-02-01

Locations

4 sites across 1 country: Italy