Status:
UNKNOWN
PHYSICAL ACTIVITY AND FVIII CLEARANCE: RELEVANCE FOR PERSONALIZED THERAPY IN SEVERE HAEMOPHILIA A (PHYSEMO)
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Hemophilia A
Eligibility:
MALE
12-60 years
Phase:
NA
Brief Summary
In persons with severe haemophilia A (HA) infused factor VIII (FVIII) half-life and other pharmacokinetic parameters can vary according to determinants such as blood group, von Willebrand factor (VWF)...
Detailed Description
Background In persons with severe haemophilia A (HA) infused factor VIII (FVIII) half-life and other pharmacokinetic parameters can vary according to determinants such as blood group, von Willebrand f...
Eligibility Criteria
Inclusion
- Patients (12-60 yr. old) with severe HA under FVIII concentrates prophylaxis will be selected at the Haemostasis and Thrombosis Center of the Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Rome, Italy (FPG) and at the satellite site at the Department of Cellular Biotechnology and Haemathology, Policlinico Umberto I, Sapienza University of Rome, Italy (UNSA\_SS).
Exclusion
- All patients with malignant tumors, or treated with anticoagulant / antiplatelet agents, and suffering from other congenital coagulation disorders (von disease Willebrand disease, other congenital deficiency of coagulation factors) or severe thrombocytopenia (\<30,000 Plt /μL).
- Patients who would have undergone a severe bleed or surgery during the past 3 months before enrolment.
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04303936
Start Date
January 9 2020
End Date
December 30 2020
Last Update
March 11 2020
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome, Italy, 00168