Study Evaluating Liver Transplantation in Haemophilia Patients in Spain
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00927992
First received: June 24, 2009
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
| Condition | Intervention |
|---|---|
|
Hemophilia Hemophilia B |
Other: Epidemiological Non interventional |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Liver Transplantation in Haemophilia Patients in Spain |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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:
- Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation [ Time Frame: Up to Day 5 post liver transplantation ] [ Designated as safety issue: No ]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 [ Time Frame: Up to Day 5 post liver transplantation ] [ Designated as safety issue: No ]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 [ Time Frame: Post liver transplantation up to Month 3 ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | July 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
Other Name: Epidemiological Non interventional
|
Detailed Description:
Probability Sample
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00927992 History of Changes |
| Other Study ID Numbers: | B1831011, 3082B1-4436 |
| Study First Received: | June 24, 2009 |
| Results First Received: | December 20, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Additional relevant MeSH terms:
|
Hemophilia B Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |
ClinicalTrials.gov processed this record on June 17, 2013