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

February 23, 2016 updated by: Instituto Grifols, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • A.O.U. Policlinico Università di Modena e Reggio Emilia
      • Padova, Italy, 35128
        • Az. Ospedaliera Universitaria di Padova
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
      • Torino, Italy, 10126
        • Az. Ospedaliera S.Giovanni Battista di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Niuliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First six and twelve months after liver transplantation
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
Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During and after each product administration (during the 12 month treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Grifols, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IG0907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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