HBV induced liver disease. MedDRA version: 9.1 Level: LLT Classification code 10019731
Conditions
Interventions
Trade Name: NIULIVA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Hepatitis B immunoglobulin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Conc
Sponsors
GRIFOLS S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female. Patients from 18 to 70 years of age. Serum HBV DNA-negative determined by DNA PCR-amplification assay just prior to anhepatic phase visit. Serum HBeAg negative just prior to anhepatic phase visit. Patients who are to undergo liver transplantation due to liver disease associated to HBV. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have already experienced a liver transplantation. Patients with unknown serum HBV replication status (data on HBeAg and HBV DNA). Patients with known allergies to any component of Niuliva Patients with selective IgA deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the percentage of patients that present HBV recurrence, after the administration of Niuliva in newly liver transplanted patients due to HBV induced liver disease, during the first six months after transplantation;Secondary Objective: To determine if levels of HBsAb considered as protective are reached in order to prevent relapse and prove that these levels are maintained during the first six months after transplantation. To assess the safety and tolerability of Niuliva administration by the detection of adverse events or clinically relevant changes in vital signs.;Primary end point(s): Percentage of subjects with HBV-liver disease recurrence during the six (6) months after transplantation Percentage of subjects with HBsAb pre-infusion levels (through levels) considered as protective. | — |
Countries
Italy
Outcome results
None listed