Sickle Cell DiseaseESCORT-HUNCT02516579
European Sickle Cell Disease Cohort - Hydroxyurea
An observational study of Sickle Cell Disease, run by Theravia at 60 sites in 7 countries.
Trial summary
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Siklos
- How many people
- 1,906 participants
- Where
- 60 sitesin 7 countries
- Study dates
- Jan 2009to 20 Mar 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with sickle-cell disease
Who may be able to join
- Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
- With symptomatic sickle cell syndrome
- Treated with Siklos®
- Having been informed of the study by the initiating physician and consenting to participate to the cohort.
Who cannot join
None listed.
Trial locations and contacts
60 sites in 7 countries.
60 sites in 7 countries
France41 sites
CHU d'Amiens - Picardie - Site sud
Amiens
Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie
Aulnay-sous-Bois, 93602
Hôpital Avicenne; médecine interne
Bobigny, 93009
Hôpital Jean Verdier; médecine interne
Bondy, 93143
Hôpital Jean Verdier; pédiatrie
Bondy, 93143
CHU Bordeaux, urgences pédiatriques
Bordeaux, 33000
Hôpital Saint-André
Bordeaux
CHU Estaing, pédiatrie
Clermont-Ferrand, 63003
Hôpital Louis Mourier; pédiatrie
Colombes, 92700
Hôpital Louis Mourier; service de pédiatrie
Colombes, 92700
Centre hospitalier intercommunal de Créteil
Créteil, 94010
Hôpital Henri Mondor, centre de la Drépanocytose
Créteil, 94010
Centre Hospitalier de Gonesse, médecine interne
Gonesse, 95500
Centre Hospitalier de Gonesse, pédiatrie
Gonesse, 95500
CHU de Grenoble, hôpital Couple Enfant
Grenoble, 38700
CHU de Grenoble
Grenoble
CHU de Limoges
Limoges
Hôpital Mère-Enfant
Limoges
Hôpital Edouard Herriot, hémovigilance
Lyon, 69003
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, 69373
CHU Timone
Marseille, 13385
Hôpital de la Conception, médecine interne
Marseille, 13385
Centre Hospitalier Intercommunal André Grégoire
Montreuil, 93100
CHU Nantes, Hôpital Hôtel Dieu
Nantes, 44093
Hôpital Trousseau; pédiatrie générale
Paris, 75012
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Necker enfants, maladies infectieuses et tropicales
Paris, 75015
Hôpital Necker; biothérapie
Paris, 75015
Hôpital Necker; maladies infectieuses et tropicales
Paris, 75015
Hôpital Robert Debré, immunologie-hématologie pédiatrique
Paris, 75935
CHR Reims, American Memorial Hospital
Reims, 51100
CHU Rennes, Hôpital Pontchaillou
Rennes, 35033
CHU Rennes, hôpital Sud
Rennes, 35203
CHU Charles Nicolle
Rouen, 76000
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
Centre Hospitalier Delafontaine, médecine interne
Saint-Denis, 93205
Centre Hospitalier Delafontaine, pédiatrie
Saint-Denis, 93205
CHRU Strasbourg, Hôpital de Hautepierre
Strasbourg, 67098
CHU Toulouse; hôpital des enfants
Toulouse, 31059
Institut Universitaire du cancer; médecine interne
Toulouse, 31059
CHU Nancy, Brabois enfants
Vandœuvre-lès-Nancy, 54511
Germany6 sites
Charité-Universitätsmedizin, Berlin
Berlin
Pädiatrie Klinikum Delmenhorst
Delmenhorst
Heinrich-Heine Universität Düsseldorf
Düsseldorf
University of Freiburg
Freiburg im Breisgau
Universitätsklinikum Hamburg-Eppendorf
Hamburg
München
München
French Guiana3 sites
CH André Rosemon
Cayenne, 97306
CMCK
Kourou, 97387
CH Ouest Guyanais
Saint-Laurent-du-Maroni, 97320
Guadeloupe3 sites
CH Basse-Terre, adultes
Basse-Terre, 97100
CH Basse-Terre, enfants
Basse-Terre, 97100
CHU Pointe à Pitre
Pointe-à-Pitre, 97159
Italy3 sites
Clinica Pediatrica AOU
Naples
Azienda Ospedaliera-University of Padova
Padova
Azienda Ospedaliera Universitaria Integrata (AOUI Verona)
Verona
Martinique3 sites
CHU Fort de France
Fort-de-France, 97200
Hôpital Pierre Zobda-Quitman
Fort-de-France
CH Lamentin
Le Lamentin, 97232
About this study
Official title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
- Conditions
- Sickle Cell Disease
- Being tested
- Siklos
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiklosDrug
Also called hydrocarbamide
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Patient-years With Malignancies
Measured: During the follow-up of participant, up to 10 years
% of Patient-years With Skin Ulcerations
Patients with at least one skin ulceration
Measured: During the follow-up of participant, up to 10 years
% of Patient-years With Myelosuppressions
Patients with at least one myelosuppression
Measured: During the follow-up of participant, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJan 2009
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Galacteros, MD, Principal investigator, Hôpital henri Mondor (Adults)Mariane de Montalembert, MD, Principal investigator, Hôpital Necker Enfants Malades (Children)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516579
- Sponsor's protocol ID
- ESCORT-HU
- Acronym
- ESCORT-HU
- Status last verified
- Mar 2020
- First submitted
- 23 Jul 2015
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Allali S, Galacteros F, Oevermann L, Cannas G, Joseph L, Loko G, Elenga N, Benkerrou M, Etienne-Julan M, Castex MP, Brousse V, de Montalembert M. Hydroxyurea is associated with later onset of acute splenic sequestration crisis in sickle cell disease: Lessons from the European Sickle Cell Disease Cohort-Hydroxyurea (ESCORT-HU) study. Am J Hematol. 2024 Apr;99(4):555-561. doi: 10.1002/ajh.27214. Epub 2024 Jan 22.
PubMed 38247384de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galacteros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.
PubMed 34224583