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Completed

NCT Number: NCT00927992

Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

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

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Key information

Conditions

Hemophilia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

Probability Sample

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidemiological Non interventional

Other

Epidemiological Non interventional

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Liver Transplantation in Haemophilia Patients in Spain

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2009
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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