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)
Hôpital Necker enfants, maladies infectieuses et tropicales
🇫🇷Paris, France
Centre Hospitalier de Gonesse, médecine interne
🇫🇷Gonesse, France
CHU Timone
🇫🇷Marseille, France
CMCK
🇬🇫Kourou, French Guiana
Hôpital Louis Mourier; service de pédiatrie
🇫🇷Colombes, France
Charité-Universitätsmedizin, Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
CHU de Limoges
🇫🇷Limoges, France
CH Ouest Guyanais
🇬🇫Saint Laurent du Maroni, French Guiana
CHU Rennes, Hôpital Pontchaillou
🇫🇷Rennes, France
CHU Pointe à Pitre
🇬🇵Pointe-à-Pitre, Guadeloupe
Hôpital Jean Verdier; pédiatrie
🇫🇷Bondy, France
CHRU Strasbourg, Hôpital de Hautepierre
🇫🇷Strasbourg, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Pierre Zobda-Quitman
🇲🇶Fort de France, Martinique
CHU de Grenoble
🇫🇷Grenoble, France
Laiko General Hospital
🇬🇷Athens, Greece
Azienda Ospedaliera-University of Padova
🇮🇹Padova, Italy
Pädiatrie Klinikum Delmenhorst
🇩🇪Delmenhorst, Germany
Hôpital Mère-Enfant
🇫🇷Limoges, France
CH Basse-Terre, enfants
🇬🇵Basse-Terre, Guadeloupe
Clinica Pediatrica AOU
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Integrata (AOUI Verona)
🇮🇹Verona, Italy
Hôpital Louis Mourier; pédiatrie
🇫🇷Colombes, France
Centre hospitalier intercommunal de Créteil
🇫🇷Créteil, France
Centre Hospitalier de Gonesse, pédiatrie
🇫🇷Gonesse, France
CHU Nantes, Hôpital Hôtel Dieu
🇫🇷Nantes, France
CH André Rosemon
🇬🇫Cayenne, French Guiana
CH Lamentin
🇲🇶Le Lamentin, Martinique
CHU de Rouen - Hôpital Charles Nicolle
🇫🇷Rouen, France
München
🇩🇪München, Germany
Hôpital Saint-André
🇫🇷Bordeaux, France
CHU de Grenoble, hôpital Couple Enfant
🇫🇷Grenoble, France
Centre Hospitalier Intercommunal André Grégoire
🇫🇷Montreuil-sous-Bois, France
Hôpital de la Conception, médecine interne
🇫🇷Marseille, France
Institut d'Hématologie et d'Oncologie Pédiatrique
🇫🇷Lyon, France
Hôpital Necker; biothérapie
🇫🇷Paris, France
Hôpital Robert Debré, immunologie-hématologie pédiatrique
🇫🇷Paris, France
CHU Rennes, hôpital Sud
🇫🇷Rennes, France
CHU Charles Nicolle
🇫🇷Rouen, France
CHU Toulouse; hôpital des enfants
🇫🇷Toulouse, France
Institut Universitaire du cancer; médecine interne
🇫🇷Toulouse, France
Centre Hospitalier Delafontaine, pédiatrie
🇫🇷Saint-Denis, France
CHU Nancy, Brabois enfants
🇫🇷Vandoeuvre-lès-Nancy, France
Hôpital Necker; maladies infectieuses et tropicales
🇫🇷Paris, France
Hôpital Avicenne; médecine interne
🇫🇷Bobigny, France
Hôpital Jean Verdier; médecine interne
🇫🇷Bondy, France
Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie
🇫🇷Aulnay-sous-Bois, France
CHU Estaing, pédiatrie
🇫🇷Clermont Ferrand, France
Hôpital Henri Mondor, centre de la Drépanocytose
🇫🇷Créteil, France
Hôpital Edouard Herriot, hémovigilance
🇫🇷Lyon, France
CH Basse-Terre, adultes
🇬🇵Basse-Terre, Guadeloupe
Hôpital Trousseau; pédiatrie générale
🇫🇷Paris, France
CHR Reims, American Memorial Hospital
🇫🇷Reims, France
Centre Hospitalier Delafontaine, médecine interne
🇫🇷Saint-Denis, France
University of Freiburg
🇩🇪Freiburg, Germany
Heinrich-Heine Universität Düsseldorf
🇩🇪Düsseldorf, Germany
CHU Fort de France
🇲🇶Fort de France, Martinique
CHU Bordeaux, urgences pédiatriques
🇫🇷Bordeaux, France
CHU d'Amiens - Picardie - Site sud
🇫🇷Amiens, France