ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
1 other identifier
observational
2,093
7 countries
19
Brief 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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2020
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2025
CompletedAugust 27, 2024
August 1, 2024
5 years
December 22, 2020
August 26, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Occurrence and incidence of the number of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®
5 years
Occurrence and incidence of the number of leg ulcers
5 years
Occurrence and incidence of male fertility impairment
5 years
Occurrence and incidence of serious unexpected AEs causally related to Siklos®
5 years
Secondary Outcomes (8)
Mean age of puberty
5 years
Mean number of patients with the use of a contraception, incidence of the use of semen cryopreservation and of semen analysis performed
5 years
Incidence of the use of semen cryopreservation and of semen analysis performed
5 years
Incidence of semen analysis performed
5 years
Management of Siklos® during pregnancy and outcome of pregnancy following exposure at the time of conception or at any time during the pregnancy
5 years
- +3 more secondary outcomes
Study Arms (1)
Sickle cell disease patients treated with Siklos
Interventions
Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
Eligibility Criteria
Investigators will be recruited among physicians experienced in SCD management who are the only ones authorised to initiate Siklos® treatment hence to enrol and to follow up the participants. Investigators who are already participating in ESCORT-HU study will be asked to participate in the extension study. Patient selection will be based on a systematic sampling technique: during the recruitment period, patients fulfilling the inclusion criteria will be informed by their initiating physician about the ESCORT-HU Extension study and enrolled in case they agree to participate.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theravialead
- International Clinical Trials Associationcollaborator
Study Sites (87)
Amiens - Picardie Hospital Adults
Amiens, 80054, France
Amiens Picardie Hospital Children
Amiens, 80054, France
Clinique de l'Europe Amiens
Amiens, France
Angers Hospital Adults
Angers, 49933, France
Angers Hospital Center Children
Angers, 49933, France
Robert Ballanger Hospital Adults
Aulnay-sous-Bois, 93602, France
Robert Ballanger Hospital Children
Aulnay-sous-Bois, 93602, France
Avicenne Hospital Adults
Bobigny, 93009, France
Jean Verdier Hospital Children
Bondy, 93143, France
Bordeaux Hospital Adults
Bordeaux, 33000, France
Bordeaux Hospital Children
Bordeaux, 33000, France
Ambroise Paré Hospital Children
Boulogne-Billancourt, 92100, France
Tours Regional University Hospital Center Adults
Chambray-lès-Tours, 37170, France
Estaing Hospital Children
Clermont-Ferrand, 63003, France
Louis Mourier Hospital Adults
Colombes, 92700, France
Louis Mourier Hospital Children
Colombes, 92700, France
Sud Francilien Hospital Center Adults
Corbeil-Essonnes, 91100, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Sud Oise Public Hospital Group Adults
Creil, 60100, France
Henri Mondor Hospital Adults
Créteil, 94010, France
Intercommunal Hospital Center of Créteil Adults and Children
Créteil, 94010, France
Dreux Hospital Center Children
Dreux, 28102, France
Gonesse Hospital Children
Gonesse, 95500, France
Marne-La-Vallée Hospital Center Children
Jossigny, 77600, France
Grenoble Hospital Adults
La Tronche, 38700, France
Grenoble Hospital Children
La Tronche, 38700, France
Bicêtre Hospital Adults
Le Kremlin-Bicêtre, 94270, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CH du Mans
Le Mans, France
Jeanne De Flandre Hospital Children
Lille, 59037, France
Hôpital Saint-Vincent de Paul
Lille, France
Hôpital Mère-Enfant - CHU de Limoges
Limoges, France
Edouard Herriot Hospital Adults
Lyon, 69003, France
Hematology and oncology institute Children
Lyon, 69373, France
Timone Hospital Adults
Marseille, 13005, France
Timone Hospital Children
Marseille, France
Meaux Hospital Center Adults
Meaux, 77100, France
Meaux Hospital Center Children
Meaux, 77100, France
St Eloi Hospital Adults
Montpellier, 34070, France
Montpellier Hospital Children
Montpellier, 34295, France
Emile Muller Hospital Adults
Mulhouse, 68100, France
Nantes Hospital Children
Nantes, 44000, France
Nantes Hospital Adults
Nantes, 44093, France
Nice Hospital Children
Nice, 06200, France
Orléans Hospital Adults
Orléans, 45066, France
Armand Trousseau Hospital Children
Paris, 75012, France
Saint-Antoine Hospital Adults
Paris, 75012, France
Georges Pompidou European Hospital Adults
Paris, 75015, France
Necker Hospital Adults
Paris, 75015, France
Necker Hospital Children
Paris, 75015, France
Robert Debré Hospital Children
Paris, 75019, France
Centre hospitalier Perpignan
Perpignan, France
Poitiers Hospital Adults
Poitiers, 86020, France
American Hospital Children
Reims, 51100, France
Reims Hospital Adults
Reims, 51100, France
Pontchaillou Hospital Adults
Rennes, 35033, France
Charles Nicolle Hospital Adults
Rouen, 76000, France
Rouen Hospital Children
Rouen, 76000, France
Yves Le Foll. Hospital Center Children
Saint-Brieuc, 22000, France
Delafontaine Hospital Center Adults
Saint-Denis, 93200, France
Delafontaine Hospital Center Children
Saint-Denis, 93200, France
Saint-Quentin Hospital Center Adults
Saint-Quentin, 02321, France
Hautepierre Hospital Children
Strasbourg, 67098, France
Children Hospital
Toulouse, 31059, France
Toulouse University Institute of cancer Adults
Toulouse, 31059, France
Clocheville Regional University Hospital Center Children
Tours, 37000, France
Nancy Hospital Children
Vandœuvre-lès-Nancy, 54500, France
Versailles Hospital Center Children
Versailles, 78157, France
CH de Cayenne
Cayenne, 97300, French Guiana
Centre hospitalier de Kourou Children
Kourou, 97387, French Guiana
Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults
Saint-Laurent-du-Maroni, 97393, French Guiana
Centre Hospitalier de l'Ouest Guyanais Franck Joly Children
Saint-Laurent-du-Maroni, 97393, 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, 97159, Guadeloupe
Hôpital RICOU - CHU Pointe-à-Pitre Abymes
Pointe-à-Pitre, 97159, Guadeloupe
AUO Policlinico di Modena
Modena, Italy
Napoli Hospital Children
Napoli, Italy
Padova Hospital Children
Padua, Italy
Verona Hospital Children
Verona, Italy
CHU Fort de France Children
Fort-de-France, 97261, Martinique
CHU Martinique Adults
Le Lamentin, 97232, Martinique
CHU Sud Réunion
Saint-Pierre, Reunion
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mariane de Montalembert, MD, PhD
Hospital Necker enfants malades
- STUDY CHAIR
Frédéric Galactéros, MD, PhD
Henri Mondor University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
January 13, 2021
Study Start
August 21, 2020
Primary Completion
August 21, 2025
Study Completion
August 21, 2025
Last Updated
August 27, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share