Liver Transplantation in Haemophilia Patients in Spain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Primary Endpoint
- Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
Study Overview
Brief Summary
This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
Detailed Description
Probability Sample
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
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.
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
- Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation(Up to Day 5 post liver transplantation)
- Dose of Exogenous Clotting Factors Used During Liver Transplantation(Up to Day 5 post liver transplantation)
- 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)