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

Condition(s) targeted: Hepatitis B; Liver Transplantation

Intervention: Hepatitis B immune globulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Instituto Grifols, S.A.

Official(s) and/or principal investigator(s):
Paolo de Simone, MD, Principal Investigator, Affiliation: Azienda Ospedaliero, Universitaria Pisana

Overall contact:
Antonio Páez, MD, Phone: +34 935710700, Email: antonio.paez@grifols.com

The aim of this clinical trial is to evaluate the efficacy and safety 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 months post-transplantation.

In addition, the safety and tolerability of the administration of Niuliva will also be assessed.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

HBV recurrence

HBsAb pre-infusion levels (through levels before each Niuliva administration)

Secondary outcome: Safety and tolerance

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

- Evidence of hepatocellular carcinoma in the transplanted liver, or metastatic

disease, at time of inclusion in the clinical trial.

- 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 7 months.

- Subject is incapable of giving consent personally.

Antonio Páez, MD, Phone: +34 935710700, Email: antonio.paez@grifols.com

A.O.U. Policlinico Università di Modena e Reggio Emilia, Modena 41100, Italy; Recruiting
Giorgio E Gerunda, MD, Phone: +39 0594223660, Email: gerunda.giorgioenrico@unimore.it
Giorgio E Gerunda, MD, Principal Investigator

Az. Ospedaliera Universitaria di Padova, Padova 35128, Italy; Recruiting
Umberto Cillo, MD, Phone: +39 049 8212236, Email: cillo@unipd.it
Umberto Cillo, MD, Principal Investigator

Azienda Ospedaliero Universitaria Pisana, Pisa 56124, Italy; Recruiting
Paolo de Simone, MD, Phone: +39 050995421, Email: p.desimone@ao-pisa.toscana.it
Paolo de Simone, MD, Principal Investigator

Az. Ospedaliera S.Giovanni Battista di Torino, Torino 10126, Italy; Recruiting
Mauro Salizzoni, MD, Phone: +39 011 6334374, Email: msalizzoni@molinette.piemonte.it
Mauro Salizzoni, MD, Principal Investigator

Starting date: September 2010
Last updated: August 28, 2012