Study Evaluating Liver Transplantation in Haemophilia Patients in Spain

NCT00927992 | Completed Results

• 2 other identifiers: B18310113082B1-4436
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hemophilia; Hemophilia B

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Epidemiological Non interventional OTHER

Epidemiological Non interventional

Patients with haemophilia who undergo liver transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients without informed consent form.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No outcomes were specified in the study protocol. Designation of outcomes as primary and secondary was based on study team's input as study neither specifies nor prioritizes the outcomes.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 30, 2013
• Results First Posted: January 30, 2013

Record last verified: 2012-12