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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Grifols Biologicals Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT01131065
First received: May 25, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 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 (through levels before each Niuliva administration) [ Time Frame: First six months after liver transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerance [ Time Frame: During and after each product administration (during the 6 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.


Estimated Enrollment: 15
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatitis B immune globulin
Treatment group
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, and 6, respectively.
Other Name: Niuliva

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01131065

Contacts
Contact: Antonio Páez, MD +34 935710700 antonio.paez@grifols.com
Contact: Michael K Woodward, BSc +34 935710700 mwoodward@grifols.com

Locations
Italy
A.O.U. Policlinico Università di Modena e Reggio Emilia Recruiting
Modena, Italy, 41100
Contact: Giorgio E Gerunda, MD    +39 0594223660    gerunda.giorgioenrico@unimore.it   
Principal Investigator: Giorgio E Gerunda, MD         
Az. Ospedaliera Universitaria di Padova Recruiting
Padova, Italy, 35128
Contact: Umberto Cillo, MD    +39 049 8212236    cillo@unipd.it   
Principal Investigator: Umberto Cillo, MD         
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56124
Contact: Paolo de Simone, MD    +39 050995421    p.desimone@ao-pisa.toscana.it   
Principal Investigator: Paolo de Simone, MD         
Az. Ospedaliera S.Giovanni Battista di Torino Recruiting
Torino, Italy, 10126
Contact: Mauro Salizzoni, MD    +39 011 6334374    msalizzoni@molinette.piemonte.it   
Principal Investigator: Mauro Salizzoni, MD         
Sponsors and Collaborators
Instituto Grifols, S.A.
Investigators
Principal Investigator: Paolo de Simone, MD Azienda Ospedaliero, Universitaria Pisana
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT01131065     History of Changes
Other Study ID Numbers: IG 0907
Study First Received: May 25, 2010
Last Updated: March 18, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Grifols Biologicals Inc.:
Hepatitis B
HBV
Orthotopic liver transplantation
Liver transplantation
Recurrence
Reinfection
Protective titers
HBsAb
Hepatitis B virus immune globulin
Niuliva

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Recurrence
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
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014