Hemophilia, Hemophilia B
Conditions
Brief summary
This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
Detailed description
Probability Sample
Interventions
OTHEREpidemiological Non interventional
Epidemiological Non interventional
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemophiliac Participants With Liver Transplant Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Hemophiliac Participants With Liver Transplant |
|---|---|
| Age Continuous | 45.45 years STANDARD_DEVIATION 15.38 |
| Number of participants with Type A and B Hemophilia Type A | 9 participants |
| Number of participants with Type A and B Hemophilia Type B | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation
Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.
Time frame: Post liver transplantation up to Month 3
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Cyclosporine | 7 Participants |
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Corticosteroids | 6 Participants |
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Tacrolimus | 4 Participants |
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Mycophenolate Mofetil | 3 Participants |
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation | Everolimus | 1 Participants |
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.
Time frame: Post liver transplantation up to Month 3
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hemophiliac Participants With Liver Transplant | Number of Participants Who Survived After Liver Transplantation | 10 Participants |
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.
Time frame: Post liver transplantation up to Month 3
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hemophiliac Participants With Liver Transplant | Number of Participants With Acute Rejection of Liver Transplant | 0 Participants |
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.
Time frame: Post liver transplantation up to Month 3
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hemophiliac Participants With Liver Transplant | Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation | 4 Participants |
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.
Time frame: Up to Day 5 post liver transplantation
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemophiliac Participants With Liver Transplant | Dose of Exogenous Clotting Factors Used During Liver Transplantation | 62.88 International Unit/kilogram (IU/kg) | Standard Deviation 30.09 |
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.
Time frame: Up to Day 5 post liver transplantation
Population: Evaluable population included all the participants who met the eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation | Bolus | 5 Participants |
| Hemophiliac Participants With Liver Transplant | Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation | Continuous infusion | 3 Participants |
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
Time frame: Post liver transplantation up to Month 3
Population: Data was not analyzed as only hemophiliac participants were enrolled in the study.