Hemophilia B Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation. | Post liver transplantation up to Month 3 | No |
| Primary | Number of Participants With Acute Rejection of Liver Transplant | Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist. | Post liver transplantation up to Month 3 | No |
| Primary | Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation | 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. | Post liver transplantation up to Month 3 | No |
| Primary | Number of Participants Who Survived After Liver Transplantation | 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. | Post liver transplantation up to Month 3 | No |
| Secondary | Number of Participants Requiring Exogenous Clotting Factor Infusion During 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. | Up to Day 5 post liver transplantation | No |
| Secondary | Dose of Exogenous Clotting Factors Used During 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. | Up to Day 5 post liver transplantation | No |
| Secondary | Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation | Post liver transplantation up to Month 3 | No |
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