drugset / Trial / NCT01131065

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

NCT01131065

Phase 3 Completed 15 enrolled Grifols, S.A.
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2010-07
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject hepatitis B immune globulin Protein / enzyme biologic 5000 iu Intravenous