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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131065
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : February 1, 2016
Last Update Posted : February 25, 2016
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Transplantation Drug: Hepatitis B immune globulin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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.
Study Start Date : July 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. 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 :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Instituto Grifols, S.A. Identifier: NCT01131065     History of Changes
Other Study ID Numbers: IG0907
First Posted: May 26, 2010    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: February 25, 2016
Last Verified: February 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