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ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
Sponsor: Theravia
Summary
As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.
Official title: ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2093
Start Date
2020-08-21
Completion Date
2025-08-21
Last Updated
2024-08-27
Healthy Volunteers
No
Conditions
Interventions
Hydroxycarbamide
Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
Locations (87)
Amiens - Picardie Hospital Adults
Amiens, France
Amiens Picardie Hospital Children
Amiens, France
Clinique de l'Europe Amiens
Amiens, France
Angers Hospital Adults
Angers, France
Angers Hospital Center Children
Angers, France
Robert Ballanger Hospital Adults
Aulnay-sous-Bois, France
Robert Ballanger Hospital Children
Aulnay-sous-Bois, France
Avicenne Hospital Adults
Bobigny, France
Jean Verdier Hospital Children
Bondy, France
Bordeaux Hospital Adults
Bordeaux, France
Bordeaux Hospital Children
Bordeaux, France
Ambroise Paré Hospital Children
Boulogne-Billancourt, France
Tours Regional University Hospital Center Adults
Chambray-lès-Tours, France
Estaing Hospital Children
Clermont-Ferrand, France
Louis Mourier Hospital Adults
Colombes, France
Louis Mourier Hospital Children
Colombes, France
Sud Francilien Hospital Center Adults
Corbeil-Essonnes, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Sud Oise Public Hospital Group Adults
Creil, France
Henri Mondor Hospital Adults
Créteil, France
Intercommunal Hospital Center of Créteil Adults and Children
Créteil, France
Dreux Hospital Center Children
Dreux, France
Gonesse Hospital Children
Gonesse, France
Marne-La-Vallée Hospital Center Children
Jossigny, France
Grenoble Hospital Adults
La Tronche, France
Grenoble Hospital Children
La Tronche, France
Bicêtre Hospital Adults
Le Kremlin-Bicêtre, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CH du Mans
Le Mans, France
Jeanne De Flandre Hospital Children
Lille, France
Hôpital Saint-Vincent de Paul
Lille, France
Hôpital Mère-Enfant - CHU de Limoges
Limoges, France
Edouard Herriot Hospital Adults
Lyon, France
Hematology and oncology institute Children
Lyon, France
Timone Hospital Adults
Marseille, France
Timone Hospital Children
Marseille, France
Meaux Hospital Center Adults
Meaux, France
Meaux Hospital Center Children
Meaux, France
St Eloi Hospital Adults
Montpellier, France
Montpellier Hospital Children
Montpellier, France
Emile Muller Hospital Adults
Mulhouse, France
Nantes Hospital Children
Nantes, France
Nantes Hospital Adults
Nantes, France
Nice Hospital Children
Nice, France
Orléans Hospital Adults
Orléans, France
Armand Trousseau Hospital Children
Paris, France
Saint-Antoine Hospital Adults
Paris, France
Georges Pompidou European Hospital Adults
Paris, France
Necker Hospital Adults
Paris, France
Necker Hospital Children
Paris, France
Robert Debré Hospital Children
Paris, France
Centre hospitalier Perpignan
Perpignan, France
Poitiers Hospital Adults
Poitiers, France
American Hospital Children
Reims, France
Reims Hospital Adults
Reims, France
Pontchaillou Hospital Adults
Rennes, France
Charles Nicolle Hospital Adults
Rouen, France
Rouen Hospital Children
Rouen, France
Yves Le Foll. Hospital Center Children
Saint-Brieuc, France
Delafontaine Hospital Center Adults
Saint-Denis, France
Delafontaine Hospital Center Children
Saint-Denis, France
Saint-Quentin Hospital Center Adults
Saint-Quentin, France
Hautepierre Hospital Children
Strasbourg, France
Children Hospital
Toulouse, France
Toulouse University Institute of cancer Adults
Toulouse, France
Clocheville Regional University Hospital Center Children
Tours, France
Nancy Hospital Children
Vandœuvre-lès-Nancy, France
Versailles Hospital Center Children
Versailles, France
CH de Cayenne
Cayenne, French Guiana
Centre hospitalier de Kourou Children
Kourou, French Guiana
Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults
Saint-Laurent-du-Maroni, French Guiana
Centre Hospitalier de l'Ouest Guyanais Franck Joly Children
Saint-Laurent-du-Maroni, French Guiana
Charité Hospital Children
Berlin, Germany
Düsseldorf Hospital Children
Düsseldorf, Germany
Freiburg Hospital Children
Freiburg im Breisgau, Germany
Hamburg Hospital Children
Hamburg, Germany
Koblenz Hospital Children
Koblenz, Germany
Laiko General Hospital Adults
Athens, Greece
Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children
Pointe-à-Pitre, Guadeloupe
Hôpital RICOU - CHU Pointe-à-Pitre Abymes
Pointe-à-Pitre, Guadeloupe
AUO Policlinico di Modena
Modena, Italy
Napoli Hospital Children
Naples, Italy
Padova Hospital Children
Padova, Italy
Verona Hospital Children
Verona, Italy
CHU Fort de France Children
Fort-de-France, Martinique
CHU Martinique Adults
Le Lamentin, Martinique
CHU Sud Réunion
Saint-Pierre, Reunion