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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT06464458
Eligibility Criteria:
Inclusion criteria:
* Subjects aged between 2 and 35 years.
* For very young children hydroxyurea is only initiated in cases of severe sickle cell disease.
* Sickle cell genotype: HbSS
* Subjects who have been hospitalised for CVO in the last 3 months and for whom HU treatment is to be initiated and/or whose treatment is not balanced or is less than 30 mg/kg, regardless of the length of treatment
* For a woman of childbearing potential:
* Negative blood pregnancy test at the inclusion visit
* Patient accepting highly effective contraception for the duration of study participation and 182 days after discontinuation of the study or treatment.
* Initiation of HU treatment in a patient requiring intensification of therapy in the context of sickle cell disease
* Patient hospitalised (e.g. vaso-occlusive crisis) and/or whose HU treatment is not balanced (MTD not reached)
* Informed consent signed, as appropriate, by :
* The patient and/or
* The holder(s) of parental authority and the minor subject if capable of discernment
* Subject affiliated to a social health insurance scheme or beneficiary
* Subject who has been informed of the results of the prior medical examination, and/or of whom the holder(s) of parental authority has (have) been informed
* Subject able to understand the objectives and risks of the research and to give dated and signed informed consent
Exclusion criteria:
* HU patient who has achieved MTD (based on haematological criteria) or is not therapeutically ineffective or hydroxyurea dosage \> 35 mg/kg/day.
* Refusal to accept the use of a highly effective contraceptive method as defined during HU treatment and for 182 days for females and 92 days for males following such treatment (fertile patients only)
* Patient with a parental plan within 18 months
* Hypersensitivity to the active substance or to any of the excipients of the medicinal product
* Severe hepatic impairment
* Severe renal insufficiency
* Toxic signs of myelosuppression
* Neutrophils \< 1500/mm3
* Platelets \< 80 000/mm3
* Haemoglobin \< 4.5 g/dL
* Reticulocytes \< 80,000/mm3 if haemoglobin concentration \< 9 g/dL
* Patient with transfusion, exchange transfusion or erythropoietin administration within 3 months of inclusion
* Patient with HIV
* Unable to give subject informed information (subject in emergency situation)
* Inability of the subject to undergo the medical follow-up of the trial for geographical, social or psychological reasons
* Subject under guardianship or curatorship
* Pregnancy or breastfeeding in the case of adolescents or adults
* Subject in an exclusion period (determined by a previous or ongoing study)
* Concurrent inclusion in another drug study
* Subject under court protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
35 Years
Study:
NCT06464458
Study Brief:
Protocol Section:
NCT06464458