Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00927992
First received: June 24, 2009
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain


Condition Intervention
Hemophilia
Hemophilia B
Other: Epidemiological Non interventional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Liver Transplantation in Haemophilia Patients in Spain

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]
    Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.

  • Number of Participants With Acute Rejection of Liver Transplant [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]
    Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.

  • Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Who Survived After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ] [ Designated as safety issue: No ]
    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.

  • Dose of Exogenous Clotting Factors Used During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: Epidemiological Non interventional

Detailed Description:

Probability Sample

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927992

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

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00927992     History of Changes
Other Study ID Numbers: B1831011, 3082B1-4436
Study First Received: June 24, 2009
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on April 16, 2014