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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05199766
Eligibility Criteria:
Inclusion Criteria:
* SS or S-β0 major sickle cell syndrome
* Hemoglobin level \< 9 g/dL
* Aged 18 years or older
* Stable dose for at least 3 months if treated with HU, EPO, angiotensin-converting enzyme (ACE) or inhibitor/angiotensin receptor blocker (ARB) therapy; at least after 6 months after initiating HU treatment
* Patient with social security
* Female patient must have a negative serum pregnancy test (betaHCGat inclusion W0-V1D1) or evidence of post-menopausal status
* Effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) or abstinence from screening through 4 weeks after last Voxelotor dose.
Exclusion Criteria:
-If patient does not have any of the following treatments (HU, Crizanlizumab) he will then be excluded if: Patient meets, at screening, Hydroxyurea/ Crizanlizumab indications of treatment (recurrent painful vaso-occlusive crises, including acute chest syndrome), even if these treatments are inappropriate (e.g. hematologic toxicity antecedent) or if the patient refuses these treatments
* Patients in chronic transfusion program or transfused \< 3 months before enrolment
* Patient with severe organ involvement: hepatic (TP \<50%), renal (eGFR\<30 ml / ml/1.73m2 according to CKD/EPI or cardiac (LVEF \<45%)
* Transplant patients.
* Pregnancy.
* Breast feeding patients
* Homeless patient
* Patient deprived of liberty by judicial or administrative decision or patient under guardianship
* Patient unable to understand the purpose and conditions of the study and unable to give consent
* Chronic use of NSAIDs (more than 10 days by month)
* Auto immune disease or infection not controlled or cancer
* VIH, HBV, HCV current infection
* Prior drug hypersensitivity to Voxelotor or excipients
* Known allergy or hypersensitivity to imaging contrast product
* Ongoing therapeutic study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05199766
Study Brief:
Protocol Section:
NCT05199766