Evaluation of a new paediatric formulation of hydroxycarbamide in children with sickle cell disease
- Conditions
- DrepanocytosisMedDRA version: 21.0Level: LLTClassification code 10051835Term: DrepanocytosisSystem Organ Class: 100000004850Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
- Registration Number
- EUCTR2022-000168-22-FR
- Lead Sponsor
- Addmedica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 45
• Written informed consent, signed and dated by both parents or by the legally
acceptable representative(s) of the children,
• Child with sickle cell disease, treated with 100 mg and/or 1000 mg Siklos® filmcoated tablets, at the same daily dose for more than 4 weeks,
• Child aged between 2 and 6 years old,
• Parents capable of communicating with the investigator and understanding the
requirements and constraints of the study protocol and willing to comply with the
study requirements,
• Children affiliated to a social security plan (including universal health coverage) or
beneficiary of a similar insurance plan.
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Participation in any other clinical study for any other pharmaceutical product within
4 weeks preceding study inclusion,
• Known hypersensitivity or allergy to the excipients,
• Any surgical or medical condition or any significant illness that, in the opinion of
the investigator, constitutes a risk or a contraindication to the participation of the
patient to the study, or that may interfere with the objectives, conduct or evaluation
of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method