CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Hepatitis B immune globulindrug
Likely dose
Hepatitis B immune globulin 10,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01131065
NCT01131065Phase 3Completed
CompareCT.gov

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

Instituto Grifols, S.A.·interventional·Posted May 26, 2010·Updated Feb 25, 2016

In Brief

A Phase 3 clinical trial evaluating Hepatitis B immune globulin for Hepatitis B and Liver Transplantation. Completed, enrolled 15 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Liver Transplantation
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartJul 1, 2010
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.1 years ago

Interventions

Hepatitis B immune globulindrug

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.