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

Primary Purpose

Hepatitis B, Liver Transplantation

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Hepatitis B immune globulin
Sponsored by
Instituto Grifols, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, HBV, Orthotopic liver transplantation, Liver transplantation, Recurrence, Reinfection, Protective titers, HBsAb, Hepatitis B virus immune globulin, Niuliva

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • A.O.U. Policlinico Università di Modena e Reggio Emilia
  • Az. Ospedaliera Universitaria di Padova
  • Azienda Ospedaliero Universitaria Pisana
  • Az. Ospedaliera S.Giovanni Battista di Torino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatitis B immune globulin

Arm Description

Treatment group (newly liver transplanted subjects due to HBV induced liver disease)

Outcomes

Primary Outcome Measures

HBV Recurrence
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)

Secondary Outcome Measures

Safety and Tolerance
Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.

Full Information

First Posted
May 25, 2010
Last Updated
February 23, 2016
Sponsor
Instituto Grifols, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01131065
Brief Title
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
Official Title
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Grifols, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Liver Transplantation
Keywords
Hepatitis B, HBV, Orthotopic liver transplantation, Liver transplantation, Recurrence, Reinfection, Protective titers, HBsAb, Hepatitis B virus immune globulin, Niuliva

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatitis B immune globulin
Arm Type
Experimental
Arm Description
Treatment group (newly liver transplanted subjects due to HBV induced liver disease)
Intervention Type
Drug
Intervention Name(s)
Hepatitis B immune globulin
Other Intervention Name(s)
Niuliva
Intervention Description
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.
Primary Outcome Measure Information:
Title
HBV Recurrence
Description
HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity
Time Frame
First six and twelve months after liver transplantation
Title
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 Measure Information:
Title
Safety and Tolerance
Description
Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.
Time Frame
During and after each product administration (during the 12 month treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Facility Information:
Facility Name
A.O.U. Policlinico Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Az. Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Az. Ospedaliera S.Giovanni Battista di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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