ENSAYO CLÍNICO

Reclutando

Fase IV

Coagulopatías hemorrágicas, Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Linfoma no Hodgkin, --> Otros, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Trombosis y Anticoagulantes, Linfoma

Diciembre, 2020

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1. Participants can be of any age at the time of enrolment into the trial. 2. Male persons with hemophilia A (HA), of any severity, who have a historical inhibitor titre 0.6 BU/mL, including those who have failed previous ITI attempt(s) 3. Persons undergoing ITI with Nuwiq®, octanate® or wilate® or undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, aPCC or rFVIIa 4. Participants or participants parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents

1. Participants are excluded from the trial if any coagulation disorder other than HA is diagnosed 2. Partly retrospective patients will be excluded if detailed documentation on treatment, all BEs, inhibitor titres and FVIII levels is not available for the retrospective period

The primary objective for Groups 1 and 2 is to evaluate ITI outcomes as determined by achievement of the following ITI criteria: 1. Inhibitor titre < 0.6 Bethesda units (BU)/mL for at least 2 consecutive measurements 2. FVIII recovery 66% of the predefined reference value of 1.5% international units (IU)/kg body weight (BW) 3. FVIII half-life 6 h The primary objective for Group 3 is to evaluate the annualised bleeding rate (ABR) compared with the ABR in Group 1 and Group 2.

antagonistas de la vitamin k, check-point inhibitor, complement inhibitor, de novo aml, diffuse large b-cell lymphoma (dlbcl) activated b-cell type, donor lymphocyte infusion, enfermedad de von willebrand, factor xi, leucemia linfocítica crónica (llc / cll), lma de novo, vitamin k antagonist, von willebrand disease