Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04046705
Eligibility Criteria:
Inclusion criteria
* SCD patients (SS/Sβ0)
* Aged :15 to 45 years
* With at least one non-SCD sibling \> 18 years from the same parental couple
* Who presented at least one of the following criteria:
* 3 VOC requiring hospitalization over one year within the past 2 years and at least a past history of an ACS
* At least 1 ACS within the past 2 years requiring transfusions
* History of ischemic stroke or cerebral/cervical arterial stenosis \> 50%
* Pulmonary hypertension defined by mean pulmonary artery pressure ≥ 25 mmHg at rest, determined by right heart catherization
* Requiring treatment with Hydroxyurea or chronic transfusion, or already treated by Hydroxyurea or transfusion program (TP) at inclusion.
* Patients already receiving chronic transfusions for VOC or ACS not responding to hydroxyurea, will be eligible, provided at least 3 VOC requiring hospitalization/year within the 2 years before initiation of chronic transfusions, and at least past history of an ACS.
* Contraception during all the study period by sirolimus for women of child bearing potential
* Signed informed consent
* Amenable to HLA typing, HSCT if an HLA-identical sibling is available.
* Patients affiliated to the French health care insurance
Exclusion Criteria
* Performance status: ECOG scale\>1
* Pulmonary function: FEV1 et CVF \< 50% of the theorical value
* Post capillary and severe pre-capillary pulmonary hypertension with measured mean pulmonary artery pressure at rest \>35 mmHg
* Cardiac ejection fraction \< 45%
* Estimated glomerular fraction rate (GFR) \<50ml/mn /1.73m2
* Conjugate bilirubin \>50 µmole/L, cirrhosis, ALT\>4N
* Uncontrolled infection
* Known hypersensitivity of alemtuzumab
* Known hypersensitivity to murine proteins and to the following excepients: disodium edetate, polysorbate 80, potassium chloride, potassium phosphate monobasic, sodium chloride, dibasic sodium phosphate, water for injections
* Positivity for HIV
* Pregnancy or breast-feeding women
* Alloimmunization or Delayed Hemolytic Transfusion Reaction precluding red cell transfusions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT04046705
Study Brief:
Protocol Section:
NCT04046705