Dettagli per singolo studio

DEC-NET Serial number FR318

Published online	13/09/2004 10.26.00
Last updated	02/09/2005 15.37.28

Other protocol ID number	RBM2-09
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	SICKLE CELL DISEASE NOS
Experimental drug
HYDROXYCARBAMIDE Treatment regimen (dosage and duration) 15 - 20mg/kg/day during 1 day
Gender	Both
Age (range)	3 - 18 years
Eligibility criteria
Inclusion criteria
- Children with homozygous sickle cell (SS) disease, > 3 years, with parents from sub-Saharian Africa, distant from an infectious, acute anaemic or vaso-occlusive episode. - Patients treated for at least three months by hydroxyureafor an major vaso-occlusive disorder (> 3 hospitalization/year). - Untreated patients, with predominantly invalidating vaso-occlusive disorder( > 3 hospitalization/year) - Untreated patients, with asymptomatic sickle cell disease (age > 5 years). - Control group : brothers-sisters (genotype AA or AS), parents (genotype AS)
Exclusion criteria
-Child in acute period of the disease. -Parental refusal or child refusal (if able to express it=. -Patient receiving other drugs that oracilline, speciafoline, hydroxyurea or iron supplementation. - Sick control patient. -Control patient receiving any drugs
Trial design/methodology
Phase	2
Kind of study
Design
Purpose of study
To explore, in sumptomatic patients treated or not by hydroxyurea, adhesion proteins expression on red blood cells, erythroid progenitors and circulating endothelial cells.




Summary of study design, objectives, and ongoing research findings
This prospective, observational study is undertaken to evaluate hydroxyurea in patients with sickle cell disease. The expression of adhesion proteins on circulating red blood cells, on erythroid progenitors and circulating endothelial cells is compared in symtomatic patients receiving or not hydroxyurea and in control patients. Additional clinical and biological parameters are also evaluated.