Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
Condition: Hepatitis B; Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Recurrence
Intervention: Hepatitis B immune globulin
Intervention description: 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.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B; HBV; Orthotopic liver transplantation; Liver transplantation; Recurrence; Reinfection; Protective titers; HBsAb; Hepatitis B virus immune globulin; Niuliva

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.