Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

December 20, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Probability Sample

Study Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post liver transplantation up to Month 3
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.
Post liver transplantation up to Month 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.
Post liver transplantation up to Month 3
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.
Post liver transplantation up to Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Day 5 post liver transplantation
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.
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
Time Frame: Post liver transplantation up to Month 3
Post liver transplantation up to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1831011
  • 3082B1-4436 (Other Identifier: Wyeth)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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