European Sickle Cell Disease Cohort - Hydroxyurea
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT02516579
- Lead Sponsor
- Theravia
- Brief Summary
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1906
- Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
- With symptomatic sickle cell syndrome
- Treated with Siklos®
- Having been informed of the study by the initiating physician and consenting to participate to the cohort.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % of Patient-years With Malignancies During the follow-up of participant, up to 10 years % of Patient-years With Skin Ulcerations During the follow-up of participant, up to 10 years Patients with at least one skin ulceration
% of Patient-years With Myelosuppressions During the follow-up of participant, up to 10 years Patients with at least one myelosuppression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
CHU d'Amiens - Picardie - Site sud
🇫🇷Amiens, France
Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie
🇫🇷Aulnay-sous-Bois, France
Hôpital Avicenne; médecine interne
🇫🇷Bobigny, France
Hôpital Jean Verdier; médecine interne
🇫🇷Bondy, France
Hôpital Jean Verdier; pédiatrie
🇫🇷Bondy, France
CHU Bordeaux, urgences pédiatriques
🇫🇷Bordeaux, France
Hôpital Saint-André
🇫🇷Bordeaux, France
CHU Estaing, pédiatrie
🇫🇷Clermont Ferrand, France
Hôpital Louis Mourier; pédiatrie
🇫🇷Colombes, France
Hôpital Louis Mourier; service de pédiatrie
🇫🇷Colombes, France
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