Informations générales (source: ClinicalTrials.gov)
ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
Observational
Theravia (Voir sur ClinicalTrials)
août 2020
août 2025
28 août 2024
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®.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Cécile ARNAUD | 29/03/2024 01:29:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Jean Verdier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Louis Mourier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER DE GONESSE | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Contact (sur clinicalTrials) | ||||
| EFS IDF SITE ARMAND TROUSSEAU | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ambroise Paré Hospital Children - 92100 - Boulogne-Billancourt - France | Contact (sur clinicalTrials) | ||||
| American Hospital Children - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Amiens - Picardie Hospital Adults - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Amiens Picardie Hospital Children - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Angers Hospital Adults - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Angers Hospital Center Children - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Bicêtre Hospital Adults - 94270 - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Bordeaux Hospital Adults - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Bordeaux Hospital Children - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier Perpignan - Perpignan - France | Contact (sur clinicalTrials) | ||||
| CH du Mans - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Charles Nicolle Hospital Adults - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Children Hospital - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique de l'Europe Amiens - Amiens - France | Contact (sur clinicalTrials) | ||||
| Clocheville Regional University Hospital Center Children - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
| Delafontaine Hospital Center Adults - 93200 - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
| Delafontaine Hospital Center Children - 93200 - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
| Dreux Hospital Center Children - 28102 - Dreux - France | Contact (sur clinicalTrials) | ||||
| Edouard Herriot Hospital Adults - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Emile Muller Hospital Adults - 68100 - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Estaing Hospital Children - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Grenoble Hospital Adults - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Grenoble Hospital Children - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Hautepierre Hospital Children - 67098 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hematology and oncology institute Children - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bicêtre - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Hôpital Mère-Enfant - CHU de Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Vincent de Paul - Lille - France | Contact (sur clinicalTrials) | ||||
| Jeanne De Flandre Hospital Children - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Marne-La-Vallée Hospital Center Children - 77600 - Jossigny - France | Contact (sur clinicalTrials) | ||||
| Meaux Hospital Center Adults - 77100 - Meaux - France | Contact (sur clinicalTrials) | ||||
| Meaux Hospital Center Children - 77100 - Meaux - France | Contact (sur clinicalTrials) | ||||
| Montpellier Hospital Children - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Nancy Hospital Children - 54500 - Vandoeuvre les nancy - France | Contact (sur clinicalTrials) | ||||
| Nantes Hospital Adults - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Nantes Hospital Children - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Nice Hospital Children - 06200 - Nice - France | Contact (sur clinicalTrials) | ||||
| Orléans Hospital Adults - 45066 - Orléans - France | Contact (sur clinicalTrials) | ||||
| Poitiers Hospital Adults - 86020 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Pontchaillou Hospital Adults - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Reims Hospital Adults - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Robert Ballanger Hospital Adults - 93602 - Aulnay-sous-Bois - France | Contact (sur clinicalTrials) | ||||
| Robert Ballanger Hospital Children - 93602 - Aulnay-sous-Bois - France | Contact (sur clinicalTrials) | ||||
| Robert Debré Hospital Children - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Rouen Hospital Children - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Saint-Quentin Hospital Center Adults - 02321 - Saint-Quentin - France | Contact (sur clinicalTrials) | ||||
| St Eloi Hospital Adults - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Sud Francilien Hospital Center Adults - 91100 - Corbeil-Essonnes - France | Contact (sur clinicalTrials) | ||||
| Sud Oise Public Hospital Group Adults - 60100 - Creil - France | Contact (sur clinicalTrials) | ||||
| Timone Hospital Adults - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Timone Hospital Children - Marseille - France | Contact (sur clinicalTrials) | ||||
| Toulouse University Institute of cancer Adults - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Tours Regional University Hospital Center Adults - 37170 - Chambray-lès-Tours - France | Contact (sur clinicalTrials) | ||||
| Versailles Hospital Center Children - 78157 - Versailles - France | Contact (sur clinicalTrials) | ||||
| Yves Le Foll. Hospital Center Children - 22000 - Saint-Brieuc - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.