Trial record 1 of 1 for:    NCT01131065
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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.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT01131065
First received: May 25, 2010
Last updated: February 23, 2016
Last verified: February 2016
Results First Received: December 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Hepatitis B
Liver Transplantation
Intervention: Drug: Hepatitis B immune globulin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Fifteen subjects (newly liver transplanted due to HBV induced liver disease) were screened in the study, all received the study medication, and all completed the clinical study.

First subject enrolled - 26 July 2010 Last subject completed - 16 June 2014


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hepatitis B Immune Globulin

Treatment group

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.


Participant Flow:   Overall Study
    Hepatitis B Immune Globulin  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hepatitis B Immune Globulin

Treatment group

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.


Baseline Measures
    Hepatitis B Immune Globulin  
Number of Participants  
[units: participants]
  15  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     15  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Italy     15  
Alcohol consumption - abstemious  
[units: participants]
  15  
Height  
[units: centimeters]
Mean (Standard Deviation)
  170.33  (8.08)  
Weight  
[units: kilogram]
Mean (Standard Deviation)
  73.73  (12.05)  
Hepatitis history  
[units: participants]
 
Has chronic HBV     15  
Has fulminant HBV     0  
[1] 18 to 70 years of age (inclusive)



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

2.  Primary:   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 ]

3.  Secondary:   Safety and Tolerance   [ Time Frame: During and after each product administration (during the 12 month treatment period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Michael Woodward, BSc, M.Sc
Organization: Instituto Grifols, S.A.
phone: +34 935712200
e-mail: michael.woodward@grifols.com



Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov 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
Health Authority: Italy: The Italian Medicines Agency