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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. ) 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: Intervention Model: Single Group Assignment
Masking: None (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. ( Instituto Grifols, S.A. ):

Primary Outcome Measures:
  • HBV Recurrence [ Time Frame: First six and twelve months after liver transplantation ]
    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 ]

Secondary Outcome Measures:
  • Safety and Tolerance [ Time Frame: During and after each product administration (during the 12 month treatment period) ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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: Instituto Grifols, S.A. 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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Grifols Biologicals Inc. ( Instituto Grifols, S.A. ):
Hepatitis B
Orthotopic liver transplantation
Liver transplantation
Protective titers
Hepatitis B virus immune globulin

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017