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

Laura Thomas-bourgneuf
+33 1 72 69 01 86
laura.thomas-bourgneuf@addmedica.com
Corinne Duguet, MD
+ 33 1 72 69 01 86
corinne.duguet@addmedica.com

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

Compensation

Unknown

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, 80054 [Active, not recruiting]
  • Amiens, France, Amiens Picardie Hospital Children, 80054 [Active, not recruiting]
  • Angers, France, Angers Hospital Adults, 49933 [Active, not recruiting]
  • Angers, France, Angers Hospital Center Children, 49933 [Recruiting]
  • Aulnay-sous-Bois, France, Robert Ballanger Hospital Adults, 93602 [Active, not recruiting]
  • Aulnay-sous-Bois, France, Robert Ballanger Hospital Children, 93602 [Active, not recruiting]
  • Bobigny, France, Avicenne Hospital Adults, 93009 [Active, not recruiting]
  • Bondy, France, Jean Verdier Hospital Children, 93143 [Not yet recruiting]
  • Bordeaux, France, Bordeaux Hospital Adults, 33000 [Active, not recruiting]
  • Bordeaux, France, Bordeaux Hospital Children, 33000 [Recruiting]
  • Boulogne-Billancourt, France, Ambroise Paré Hospital Children, 92100 [Active, not recruiting]
  • Chambray-lès-Tours, France, Tours Regional University Hospital Center Adults, 37170 [Recruiting]
  • Clermont-Ferrand, France, Estaing Hospital Children, 63003 [Active, not recruiting]
  • Colombes, France, Louis Mourier Hospital Adults, 92700 [Active, not recruiting]
  • Colombes, France, Louis Mourier Hospital Children, 92700 [Active, not recruiting]
  • Corbeil-Essonnes, France, Sud Francilien Hospital Center Adults, 91100 [Not yet recruiting]
  • Creil, France, Sud Oise Public Hospital Group Adults, 60100 [Not yet recruiting]
  • Créteil, France, Henri Mondor Hospital Adults, 94010 [Active, not recruiting]
  • Créteil, France, Intercommunal Hospital Center of Créteil Adults and Children, 94010 [Recruiting]
  • Dreux, France, Dreux Hospital Center Children, 28102 [Not yet recruiting]
  • Gonesse, France, Gonesse Hospital Children, 95500 [Active, not recruiting]
  • Jossigny, France, Marne-La-Vallée Hospital Center Children, 77600 [Recruiting]
  • La Tronche, France, Grenoble Hospital Adults, 38700 [Recruiting]
  • La Tronche, France, Grenoble Hospital Children, 38700 [Recruiting]
  • Le Kremlin-Bicêtre, France, Bicêtre Hospital Adults, 94270 [Not yet recruiting]
  • Lille, France, Jeanne De Flandre Hospital Children, 59037 [Not yet recruiting]
  • Lyon, France, Edouard Herriot Hospital Adults, 69003 [Recruiting]
  • Lyon, France, Hematology and oncology institute Children, 69373 [Active, not recruiting]
  • Marseille, France, Timone Hospital Adults, 13005 [Not yet recruiting]
  • Marseille, France, Timone Hospital Children [Not yet recruiting]
  • Meaux, France, Meaux Hospital Center Adults, 77100 [Not yet recruiting]
  • Meaux, France, Meaux Hospital Center Children, 77100 [Recruiting]
  • Montpellier, France, St Eloi Hospital Adults, 34070 [Active, not recruiting]
  • Montpellier, France, Montpellier Hospital Children, 34295 [Recruiting]
  • Mulhouse, France, Emile Muller Hospital Adults, 68100 [Active, not recruiting]
  • Nantes, France, Nantes Hospital Children, 44000 [Not yet recruiting]
  • Nantes, France, Nantes Hospital Adults, 44093 [Not yet recruiting]
  • Nice, France, Nice Hospital Children, 06200 [Not yet recruiting]
  • Orléans, France, Orléans Hospital Adults, 45066 [Recruiting]
  • Paris, France, Armand Trousseau Hospital Children, 75012 [Recruiting]
  • Paris, France, Saint-Antoine Hospital Adults, 75012 [Active, not recruiting]
  • Paris, France, Georges Pompidou European Hospital Adults, 75015 [Active, not recruiting]
  • Paris, France, Necker Hospital Adults, 75015 [Active, not recruiting]
  • Paris, France, Necker Hospital Children, 75015 [Active, not recruiting]
  • Paris, France, Robert Debré Hospital Children, 75019 [Active, not recruiting]
  • Poitiers, France, Poitiers Hospital Adults, 86020 [Not yet recruiting]
  • Reims, France, American Hospital Children, 51100 [Active, not recruiting]
  • Reims, France, Reims Hospital Adults, 51100 [Not yet recruiting]
  • Rennes, France, Pontchaillou Hospital Adults, 35033 [Active, not recruiting]
  • Rouen, France, Charles Nicolle Hospital Adults, 76000 [Active, not recruiting]
  • Rouen, France, Rouen Hospital Children, 76000 [Active, not recruiting]
  • Saint-Brieuc, France, Yves Le Foll. Hospital Center Children, 22000 [Not yet recruiting]
  • Saint-Denis, France, Delafontaine Hospital Center Adults, 93200 [Active, not recruiting]
  • Saint-Denis, France, Delafontaine Hospital Center Children, 93200 [Not yet recruiting]
  • Saint-Quentin, France, Saint-Quentin Hospital Center Adults, 02321 [Active, not recruiting]
  • Strasbourg, France, Hautepierre Hospital Children, 67098 [Recruiting]
  • Toulouse, France, Children Hospital, 31059 [Recruiting]
  • Toulouse, France, Toulouse University Institute of cancer Adults, 31059 [Recruiting]
  • Tours, France, Clocheville Regional University Hospital Center Children, 37000 [Active, not recruiting]
  • Vandoeuvre les nancy, France, Nancy Hospital Children, 54500 [Recruiting]
  • Versailles, France, Versailles Hospital Center Children, 78157 [Active, not recruiting]
  • Cayenne, French Guiana, CH de Cayenne, 97300 [Active, not recruiting]
  • Kourou, French Guiana, Centre hospitalier de Kourou Children, 97387 [Not yet recruiting]
  • Saint-Laurent-du-Maroni, French Guiana, Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults, 97393 [Not yet recruiting]
  • Saint-Laurent-du-Maroni, French Guiana, Centre Hospitalier de l'Ouest Guyanais Franck Joly Children, 97393 [Not yet recruiting]
  • Berlin, Germany, Charité Hospital Children [Not yet recruiting]
  • Düsseldorf, Germany, Düsseldorf Hospital Children [Not yet recruiting]
  • Freiburg, Germany, Freiburg Hospital Children [Not yet recruiting]
  • Hamburg, Germany, Hamburg Hospital Children [Not yet recruiting]
  • Koblenz, Germany, Koblenz Hospital Children [Active, not recruiting]
  • Athens, Greece, Laiko General Hospital Adults [Recruiting]
  • Pointe-à-Pitre, Guadeloupe, Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children, 97159 [Recruiting]
  • Pointe-à-Pitre, Guadeloupe, Hôpital RICOU - CHU Pointe-à-Pitre Abymes, 97159 [Recruiting]
  • Modena, Italy, AUO Policlinico di Modena [Not yet recruiting]
  • Napoli, Italy, Napoli Hospital Children [Not yet recruiting]
  • Padova, Italy, Padova Hospital Children [Not yet recruiting]
  • Verona, Italy, Verona Hospital Children [Not yet recruiting]
  • Fort-de-France, Martinique, CHU Fort de France Children, 97261 [Not yet recruiting]
  • Le Lamentin, Martinique, CHU Martinique Adults, 97232 [Not yet recruiting]
Last updated 2021-01-12