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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 October 19, 2014