EUCTR2014-005033-31-FR
Active, not recruiting
Phase 1
Evaluation of the impact of renal function on the pharmacokinetics of hydroxyurea (Siklos®) in patients with sickle cell disease with normal renal function, with hyperfiltration, or with renal failure. - DARH
Addmedica S.A.S0 sitesFebruary 20, 2015
ConditionsSiklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome.MedDRA version: 17.1Level: LLTClassification code 10040643Term: Sickle cell crisisSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsSIKLOS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome.
- Sponsor
- Addmedica S.A.S
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a. Age \= 18 years.
- •b. Masculin or feminin sex.
- •c. Drepanocytose (SS or S\-ß0thal) confirmed by hemoglobine electrophorese and genotype of desosxyribonucleic acid (DNA).
- •d. adhere to national insurance program.
- •e. Have given their free consent after having been informed of the goals, proceedings, and potential risks .
- •these criteria will be applied to all 3 groups. The group the subjects will belong to will be defined by the glomerular filtration rate (GFR) estimated using Chronic Kidney Disease EPIdemiology (CKD EPI) cformular without etnic criteria.
- •Underhydroxyurea (Siklos®) treatment .with stable psology for at least 1 week± 2 jours before inclusion and taken every morning at 9h ± 15 minutes.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •a. Consent refusal
- •b. Non observant patient.
- •c. Having suffered from a vaso\-occlusive crisis during the month before inclusion.
- •d. having undergone tranfusional exchange withiin the 3 months prio to inclusion.
- •e. Patients participating to anothe study or in exclusion period from a previous study.
- •f. Patients under diuretics.
- •g. Patients suffering from an intercurrent illness, particularly inflammatory, non resolved since at least 1 month.
- •h. Patiente pregnat or breast\-feeding.
- •i. Patients with no or restraint freedom.
- •j. Patients unable to understand the goal of the study therefore not able to give their consent.
Outcomes
Primary Outcomes
Not specified
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