Status:
COMPLETED
Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
3+ years
Brief Summary
In sickle cell disease (SCD), polymerisation of haemoglobin S and the resulting shape change of the red blood cells (RBC) lead to vascular occlusion and severe painful crises. Permanent inflammatory s...
Detailed Description
Plasmatic proinflammatory molecules (C-reactive protein, orosomucoid, RANTES, IL-6, IL-8, MCP-1, IL-1A, IL-1B, ET-1, IL-4, IL-10, TNFalpha, IFNgamma), hormones from the hypothalami-pituitary-adrenal a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Homozygous SS sickle cell children, aged \> 3 years, of sub-Saharian Africa extraction, in a steady-state of disease (free of any infectious or vaso-occlusive events for the 4 weeks prior to and 2 weeks after blood sampling, and transfusion-free for 4 months prior to blood sampling), taken no drug except penicillin-V, folate or iron supplementation, hydroxyurea, divided into three groups :
- children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events
- untreated children with major vaso-occlusive events
- children \> 5 year-old without a history of vaso-occlusive events Signed informed consent obtained from the subjects (if possible) and their parents
- Controls : heterozygous AS parents or siblings of the patients, and AA siblings or healthy African unrelated subjects, aged \> 3 years, taken no drug on the day of blood sampling.
- Signed informed consent obtained from the subjects (if possible) and their parents
- EXCLUSION CRITERIA:
- Children in a acute-phase of the disease
- Parent's or patient's refusal
- Taking any drug except penicillin-V, folate or iron supplementation, hydroxyurea
- Un-healthy control or taking drug
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00784082
Start Date
May 1 2009
End Date
November 1 2012
Last Update
January 31 2013
Active Locations (1)
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1
Hopital Louis Mourier
Colombes, France, 92701