Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease

NCT00784082 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2013-01-31

No results posted yet for this study

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 state and abnormal RBC adhesion to the endothelium trigger these phenomenon. Hydroxyurea (HU) is the only drug that has been shown to reduce clinical severity of SCD, and this was initially attributed to the stimulation of foetal haemoglobin (HbF). However, the clinical response does not correlate consistently with the degree and time of HbF increment, suggesting that HU clinical benefits may involve other mechanisms such as the induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.

Conditions

Interventions

DRUG

Hydroxycarbamide, Hydroxyurea (drug)

hydroxyurea 20-25 mg/kg/day since at least 3 months

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marie-Hélène Odièvre, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784082 on ClinicalTrials.gov