Clinical trial NCT01131065: Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
Official title: Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Patients from 18 to 70 years of age (both included).
* 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.
* The patient agrees to participate and comply with all the aspects of the protocol, including blood sampling, for the total duration of the study.
* Signed informed consent.

Exclusion Criteria:

* Patients who have already experienced a liver transplantation even for reasons not related to HBV infection.
* Patients with unknown serum HBV replication status (data on HBeAg and HBV DNA).
* Patients with known allergies to any component of Niuliva®.
* History of serious adverse events (SAEs) or frequent adverse events (AEs) related to the administration of human blood-derived products.
* Patient with unknown viral status for HCV, HAV, HIV type 1 and type 2
* Patients with selective IgA deficiency.
* Any haemostatic abnormality contraindicating i.v. injection according to the investigator's judgment.
* Patient suffers from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of the study results.
* Known abuse of alcohol, drugs or other chemical substances; or has done so in the past 6 months.
* Breast-feeding women or pregnant women at the time of inclusion or who are expecting to be pregnant within the next 7 months after inclusion.
* Subject has participated in any other investigational study within the last 3 months.
* Existing possibility that the patient may be treated with other products containing specific anti-hepatitis B immunoglobins (other than Niuliva®) in a period of 13 months.
* Subject is incapable of giving consent personally.

Primary outcomes:
measure: HBV Recurrence
timeFrame: First six and twelve months after liver transplantation
measure: HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)
timeFrame: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12
Secondary outcomes:
measure: Safety and Tolerance
timeFrame: During and after each product administration (during the 12 month treatment period)
Other outcomes:
Locations:
city: Modena
country: Italy
facility: A.O.U. Policlinico Università di Modena e Reggio Emilia
city: Padova
country: Italy
facility: Az. Ospedaliera Universitaria di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Torino
country: Italy
facility: Az. Ospedaliera S.Giovanni Battista di Torino
Study officials:
References: