Status:
UNKNOWN
Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors
Lead Sponsor:
Grifols Italia S.p.A
Collaborating Sponsors:
Thrombinoscope
Conditions:
Severe Hemophilia A With Inhibitor
Eligibility:
MALE
Brief Summary
This is an observational, prospective, longitudinal, multicenter, cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class (dev...
Detailed Description
Rationale: Hemophilia A is a serious and common hereditary bleeding disorder caused by deficiency of coagulation factor VIII (FVIII). Patients with this disease are treated with recombinant factor VI...
Eligibility Criteria
Inclusion
- Diagnosis of inherited, severe (FVIII:C \< 1%) or moderately severe haemophilia A (FVIII ≤ 2%)
- Any age
- Ability to comply with study methods and willingness to participate to the study
- Written informed consent.
- FOR THE LOW RESPONDERS COHORT
- \- Documented low anamnestic response after FVIII exposure (FVIII inhibitors titre \>0.6 and \< 5 BU/ml tested by Bethesda assay, Nijmegen modification). It will be included in this study those patients who have never been submitted to ITI and also those patients who have completed ITI with partial success (defined as inhibitors titre \>0.6 and \< 5 BU/ml and no increase in the INH titer \> 5 BU over treatment with FVIII)
- INCLUSION CRITERIA FOR THE HIGH RESPONDERS COHORT
- Documented high response after FVIII exposure (FVIII inhibitors titre \> 5 BU/ml tested by Bethesda assay, Nijmegen modification). It will be included in this study those patients who are potential candidates to a first or rescue ITI.
- Any historical peak ≥ 5 BU
Exclusion
- Diagnosis of acquired haemophilia
- Diagnosis of inherited mild haemophilia A (FVIII \> 2%)
- Life expectancy lower than 1 year
- Psychiatric illness and any other conditions may impair ability to comply with study methods
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01505946
Start Date
March 1 2012
End Date
June 1 2016
Last Update
June 17 2013
Active Locations (15)
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1
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Apulia, Italy, 70124
2
Ospedale Civile dell' Annunziata
Cosenza, Calabria, Italy, 87100
3
Az. Universitaria Policlinico "Federico II" Dip. Assist. di Clinica Medica
Napoli, Campania, Italy, 80131
4
UO Angiologia e Malattie della Coagulazione "Marino Golinelli" Az Osp. Policlinico S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138