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Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

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.
 
ClinicalTrials.gov Identifier: NCT00927992
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain

Condition or disease Intervention/treatment
Hemophilia Hemophilia B Other: Epidemiological Non interventional

Detailed Description:
Probability Sample
Study Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Liver Transplantation in Haemophilia Patients in Spain
Study Start Date : July 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with haemophilia who undergo liver transplantation
Patients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain.
 Other: Epidemiological Non interventional
Epidemiological Non interventional


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.

  2. Number of Participants With Acute Rejection of Liver Transplant [ Time Frame: Post liver transplantation up to Month 3 ]
    Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.

  3. Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.

  4. Number of Participants Who Survived After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]
    Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.


Secondary Outcome Measures :
  1. Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ]
    Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.

  2. Dose of Exogenous Clotting Factors Used During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ]
    Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.

  3. Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.
Criteria

Inclusion Criteria:

  • Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Exclusion Criteria:

  • Patients without informed consent form.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00927992


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00927992    
Other Study ID Numbers: B1831011
3082B1-4436 ( Other Identifier: Wyeth )
First Posted: June 25, 2009    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013
Last Verified: December 2012
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked