ESCORT-HU Extension: European Sickle Cell Disease Cohort – Hydroxyurea – Extension

About the study

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®.

Study point of contact

Corinne Duguet, MD
+ 33 1 72 69 01 86
[email protected]
Laura Thomas-bourgneuf
+33 1 72 69 01 86
[email protected]

Locations

61 France site

5 Germany sites

4 French Guiana sites

4 Italy sites

2 Guadeloupe sites

2 Martinique sites

1 Greece site

Age

> 2 Years

Study type

Observational

Gender

All

Interventions

Drug

participation requirements

Male or female patients with symptomatic SCD,
≥ 2 years old,
Treated with Siklos®,
Having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate.

To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:

Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,

New participants with any of the following criteria:

history of HU treatment for more than 5 years or
prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or
with history of leg ulcer, or
pregnant women without interruption of Siklos® 3 months before the beginning of the pregnancy or,
males treated with Siklos® whose partner is pregnant and without discontinuation of Siklos® 3 months before the beginning of the pregnancy.

Locations

  • Amiens, France, Amiens - Picardie Hospital Adults
  • Amiens, France, Amiens Picardie Hospital Children
  • Angers, France, Angers Hospital Adults
  • Angers, France, Angers Hospital Center Children
  • Aulnay-sous-Bois, France, Robert Ballanger Hospital Adults
  • Aulnay-sous-Bois, France, Robert Ballanger Hospital Children
  • Bobigny, France, Avicenne Hospital Adults
  • Bondy, France, Jean Verdier Hospital Children
  • Bordeaux, France, Bordeaux Hospital Adults
  • Bordeaux, France, Bordeaux Hospital Children
  • Boulogne-Billancourt, France, Ambroise Paré Hospital Children
  • Chambray-lès-Tours, France, Tours Regional University Hospital Center Adults
  • Clermont-Ferrand, France, Estaing Hospital Children
  • Colombes, France, Louis Mourier Hospital Adults
  • Colombes, France, Louis Mourier Hospital Children
  • Corbeil-Essonnes, France, Sud Francilien Hospital Center Adults
  • Creil, France, Sud Oise Public Hospital Group Adults
  • Créteil, France, Henri Mondor Hospital Adults
  • Créteil, France, Intercommunal Hospital Center of Créteil Adults and Children
  • Dreux, France, Dreux Hospital Center Children
  • Gonesse, France, Gonesse Hospital Children
  • Jossigny, France, Marne-La-Vallée Hospital Center Children
  • La Tronche, France, Grenoble Hospital Adults
  • La Tronche, France, Grenoble Hospital Children
  • Le Kremlin-Bicêtre, France, Bicêtre Hospital Adults
  • Lille, France, Jeanne De Flandre Hospital Children
  • Lyon, France, Edouard Herriot Hospital Adults
  • Lyon, France, Hematology and oncology institute Children
  • Marseille, France, Timone Hospital Adults
  • Marseille, France, Timone Hospital Children
  • Meaux, France, Meaux Hospital Center Adults
  • Meaux, France, Meaux Hospital Center Children
  • Montpellier, France, St Eloi Hospital Adults
  • Montpellier, France, Montpellier Hospital Children
  • Mulhouse, France, Emile Muller Hospital Adults
  • Nantes, France, Nantes Hospital Children
  • Nantes, France, Nantes Hospital Adults
  • Nice, France, Nice Hospital Children
  • Orléans, France, Orléans Hospital Adults
  • Paris, 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
  • Poitiers, France, Poitiers Hospital Adults
  • Reims, France, American Hospital Children
  • Reims, France, Reims Hospital Adults
  • Rennes, France, Pontchaillou Hospital Adults
  • Rouen, France, Charles Nicolle Hospital Adults
  • Rouen, France, Rouen Hospital Children
  • Saint-Brieuc, France, Yves Le Foll. Hospital Center Children
  • Saint-Denis, France, Delafontaine Hospital Center Adults
  • Saint-Denis, France, Delafontaine Hospital Center Children
  • Saint-Quentin, France, Saint-Quentin Hospital Center Adults
  • Strasbourg, France, Hautepierre Hospital Children
  • Toulouse, France, Children Hospital
  • Toulouse, France, Toulouse University Institute of cancer Adults
  • Tours, France, Clocheville Regional University Hospital Center Children
  • Vandoeuvre les nancy, France, Nancy Hospital Children
  • Versailles, France, Versailles Hospital Center Children
  • Cayenne, French Guiana, CH de Cayenne
  • Kourou, French Guiana, Centre hospitalier de Kourou Children
  • Saint-Laurent-du-Maroni, 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
  • Berlin, Germany, Charité Hospital Children
  • Düsseldorf, Germany, Düsseldorf Hospital Children
  • Freiburg, Germany, Freiburg Hospital Children
  • Hamburg, Germany, Hamburg Hospital Children
  • Koblenz, Germany, Koblenz Hospital Children
  • Athens, Greece, Laiko General Hospital Adults
  • Pointe-à-Pitre, Guadeloupe, Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children
  • Pointe-à-Pitre, Guadeloupe, Hôpital RICOU - CHU Pointe-à-Pitre Abymes
  • Modena, Italy, AUO Policlinico di Modena
  • Napoli, Italy, Napoli Hospital Children
  • Padova, Italy, Padova Hospital Children
  • Verona, Italy, Verona Hospital Children
  • Fort-de-France, Martinique, CHU Fort de France Children
  • Le Lamentin, Martinique, CHU Martinique Adults
Last updated 2022-03-24