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

This study has been completed.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
First received: May 25, 2010
Last updated: February 23, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Hepatitis B
Liver Transplantation
Drug: Hepatitis B immune globulin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.

Resource links provided by NLM:

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • HBV Recurrence [ Time Frame: First six and twelve months after liver transplantation ] [ Designated as safety issue: No ]
    HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity

  • HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration) [ Time Frame: Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerance [ Time Frame: During and after each product administration (during the 12 month treatment period) ] [ Designated as safety issue: Yes ]
    Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.

Enrollment: 15
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatitis B immune globulin
Treatment group (newly liver transplanted subjects due to HBV induced liver disease)
Drug: Hepatitis B immune globulin
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.
Other Name: Niuliva


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131065

A.O.U. Policlinico Università di Modena e Reggio Emilia
Modena, Italy, 41100
Az. Ospedaliera Universitaria di Padova
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Az. Ospedaliera S.Giovanni Battista di Torino
Torino, Italy, 10126
Sponsors and Collaborators
Instituto Grifols, S.A.
  More Information

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT01131065     History of Changes
Other Study ID Numbers: IG0907 
Study First Received: May 25, 2010
Results First Received: December 28, 2015
Last Updated: February 23, 2016
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Grifols Biologicals Inc.:
Hepatitis B
Orthotopic liver transplantation
Liver transplantation
Protective titers
Hepatitis B virus immune globulin

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Disease Attributes
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 03, 2016