Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

Completed

• Conditions: Hemophilia B; Hemophilia
• Interventions: Other: Epidemiological Non interventional

• Registration Number: NCT00927992
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Timeline

• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Study Start: 2009-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-12
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Results First Posted: 2013-01-30
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia who undergo liver transplantation	Epidemiological Non interventional	Patients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain.

Primary Outcome Measures

Name	Time	Method
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation	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	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	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	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 Outcome Measures

Name	Time	Method
Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation	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.
Dose of Exogenous Clotting Factors Used During Liver Transplantation	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.
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