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Optimization of the management of drepanocytosis patients treated with hydroxyurea: Interest of the pharmacological therapeutic follow-up
EU CTIS ID: 2024-515562-14-00
What this study is testing
Compare the time to reach DMT in 2 groups of patients each with a different methodology of therapeutic follow-up
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject of age between 2 and 35 years.
- Subject able to understand the objectives and risks related to the research and to give dated and signed informed conse
- Informed consent signed as the case may be, by: o the patient and/or o the holder(s) of parental authority and the minor subject if he is capable of discernment
- Sickle cell genotype: HbSS
- Subject who has been hospitalized for CVO in the last 3 months in whom hu treatment is to be initiated and / or whose treatment is not balanced or less than 30 mg / kg regardless of the age of treatment
- For a woman of childbearing age: o Negative blood pregnancy test at inclusion visit o Patient accepting highly effective contraception for the duration of participation in the study and 182 days after discontinuation of the study or treatment for a woman. The contraceptives considered highly effective are: ▪ Combined hormonal contraception (containing estrogen and progesterone) associated with ovulation inhibition: oral, intravaginal, transdermal ▪ Hormonal contraception progesterone alone associated with ovulation inhibition: oral, injectable, implantable ▪ intrauterine device ▪ intrauterine device with hormone release ▪ tubal ligation
You likely can't join if
- Patient treated with HU who has reached DMT (hematological criteria) or who does not have therapeutic ineffectiveness or hydroxyurea dosage > 350 mg / kg / day.
- Hypersensitivity to the active substance or to any of the excipients of the drug.
- Severe hepatic impairment.
- Severe renal failure.
- Toxic signs of myelosuppression o Neutrophils < 1,500/mm3 o Platelets < 80,000/mm3 o Hemoglobin < 4.5 g/dL o Reticulocytes < 80,000/mm3 if the haemoglobin concentration is < 9 g/dL
- Patient who received a transfusion, transfusion exchanges or administration of erythropoietin within 3 months before inclusion
See the full eligibility criteria
Who can join
- Subject of age between 2 and 35 years.
- Subject able to understand the objectives and risks related to the research and to give dated and signed informed conse
- Informed consent signed as the case may be, by: o the patient and/or o the holder(s) of parental authority and the minor subject if he is capable of discernment
- Sickle cell genotype: HbSS
- Subject who has been hospitalized for CVO in the last 3 months in whom hu treatment is to be initiated and / or whose treatment is not balanced or less than 30 mg / kg regardless of the age of treatment
- For a woman of childbearing age: o Negative blood pregnancy test at inclusion visit o Patient accepting highly effective contraception for the duration of participation in the study and 182 days after discontinuation of the study or treatment for a woman. The contraceptives considered highly effective are: ▪ Combined hormonal contraception (containing estrogen and progesterone) associated with ovulation inhibition: oral, intravaginal, transdermal ▪ Hormonal contraception progesterone alone associated with ovulation inhibition: oral, injectable, implantable ▪ intrauterine device ▪ intrauterine device with hormone release ▪ tubal ligation
- For men of childbearing age: patient accepting effective contraception throughout the study and for 92 days after stopping the study or treatment, use of condoms in the included patient as well as taking contraception by the partner of childbearing age.
- Initiation of HU treatment in a patient requiring therapeutic intensification in the context of sickle cell disease
- Hospitalized patient (e.g. vaso-occlusive crisis) and / or whose treatment with HU is unbalanced (DMT not reached)
- Subject affiliated to a social protection scheme for health insurance or beneficiary
- Subject who has been informed of the results of the prior medical examination, and/or whose holder(s) of parental authority has been informed(s)
What rules you out
- Patient treated with HU who has reached DMT (hematological criteria) or who does not have therapeutic ineffectiveness or hydroxyurea dosage > 350 mg / kg / day.
- Hypersensitivity to the active substance or to any of the excipients of the drug.
- Severe hepatic impairment.
- Severe renal failure.
- Toxic signs of myelosuppression o Neutrophils < 1,500/mm3 o Platelets < 80,000/mm3 o Hemoglobin < 4.5 g/dL o Reticulocytes < 80,000/mm3 if the haemoglobin concentration is < 9 g/dL
- Patient who received a transfusion, transfusion exchanges or administration of erythropoietin within 3 months before inclusion
- Subject in period of exclusion (determined by a previous or ongoing study)
- HIV-positive patient
- Inability to give informed information about (subject in emergency situation)
- Concomitant inclusion in another drug study
- Subject under safeguard of justice
- Impossibility for the subject to submit to the medical follow-up of the trial for geographical, social or psychological reasons
- Subject under guardianship or curatorship
- Pregnancy or breastfeeding in progress for teenagers or adults
- Refusal to agree to use a highly effective contraceptive method as defined during a HU treatment and during the 182 days for women and 92 days for men following this treatment (fertile patients only).
- Patient with a parental project within 18 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.