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| ID | Type | Description | Link |
|---|---|---|---|
| 3082B1-4436 | Other Identifier | Wyeth |
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This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
Probability Sample
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidemiological Non interventional | Other | Epidemiological Non interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Exogenous Clotting Factor Infusion During 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemophiliac Participants With Liver Transplant | Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemophiliac Participants With Liver Transplant | Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Number | Participants | Post liver transplantation up to Month 3 |
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There were no adverse events collected in this retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemophiliac Participants With Liver Transplant | Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Dose of Exogenous Clotting Factors Used During 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 | Post liver transplantation up to Month 3 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Number of participants with Type A and B Hemophilia | Number | participants |
|
| Participants |
|
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| Primary | 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. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Number | Participants | Post liver transplantation up to Month 3 |
|
|
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| Primary | 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. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Number | Participants | Post liver transplantation up to Month 3 |
|
|
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| Primary | 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. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Number | Participants | Post liver transplantation up to Month 3 |
|
|
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| Secondary | Number of Participants Requiring Exogenous Clotting Factor Infusion During 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. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Number | Participants | Up to Day 5 post liver transplantation |
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|
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| Secondary | Dose of Exogenous Clotting Factors Used During 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. | Evaluable population included all the participants who met the eligibility criteria. | Posted | Mean | Standard Deviation | International Unit/kilogram (IU/kg) | Up to Day 5 post liver transplantation |
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| Secondary | Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation | Data was not analyzed as only hemophiliac participants were enrolled in the study. | Posted | Post liver transplantation up to Month 3 |
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| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |