Targeting TFPI With Concizumab to Improve Haemostasis in Glanzmann Thrombasthenia Patients: an in Vitro Study
NCT06234813
Blood Coagulation Disorders, Blood Coagulation Disorders, Inherited
Bordeaux, France
View Trial DetailsNCT Number: NCT06204042
Glanzmann thrombasthenia is a rare autosomal recessive platelet disorder characterized by a lack of functional integrins alfaIIb or beta3 (glycoproteins IIb/IIIa). The prevalence is variously reported to be between 1:200,000 to 1:1,000,000, with substantial geographic variation. The clinical phenotype is dominated by an increased mucocutaneous bleeding tendency. In absence of a primary bleeding prophylaxis, the current treatment of Glanzmann thrombasthenia is mainly focused on prevention or management of bleeding. However, as potential new therapies emerge, clinicians require unbiased, long-term safety and efficacy data for both current treatment and new therapies.
We have designed this study to investigate genetic phenotype (ITGA2B and ITGB3 genes) and the prevalence of antibodies against human leucocyte antigen (HLA) and human platelet antigen (HPA), the latter two being a potential consequence of the current golden standard treatment: platelet transfusion. The results of this study will be merged with a longitudinal registry with retrospective and prospective data collection of clinical phenotype, haemorrhagic burden and bleeding management. Analysis of the data from the Glanzmann-NHS+ study and the registry will help us to get a better understanding of the clinical variation among participants with Glanzmann thrombasthenia. The ultimate goal is to accelerate improvement in the care of patients with Glanzmann thrombasthenia.
Trial opening soon.
Get Notified16 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Single measurement at Baseline
Description of mutation analysis in the ITGA2B and ITGB3 genes.
Time frame: Single measurement at Baseline
Cross-sectional evaluation of existing antibodies against Human Leucocyte Antigen (HLA) type I.
Time frame: Single measurement at Baseline
Cross-sectional evaluation of existing antibodies against Human Platelet Antigen (HPA)
UMC Utrecht
Other
Glanzmann Thrombasthenia Natural History Study+
Acronym: Glanzmann-NHS
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