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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
- ClinicalTrials.gov ID
- NCT02516579
- Acronym / sponsor ID
- ESCORT-HU / ESCORT-HU
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,906 participants (actual)
- Lead sponsor
- TheraviaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with sickle-cell disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SiklosAlso: hydrocarbamide | Drug | – |
Primary outcome
% of Patient-years With Malignancies
Time frame: During the follow-up of participant, up to 10 years
% of Patient-years With Skin Ulcerations
Time frame: During the follow-up of participant, up to 10 years
Patients with at least one skin ulceration
% of Patient-years With Myelosuppressions
Time frame: During the follow-up of participant, up to 10 years
Patients with at least one myelosuppression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38247384Allali 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.
- Derived from this study: PubMed 34224583de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Galacteros, MD principal investigator
Hôpital henri Mondor (Adults)
Mariane de Montalembert, MD principal investigator
Hôpital Necker Enfants Malades (Children)
60 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Theravia at 60 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in France, Germany, French Guiana, Guadeloupe, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Patient-years With Malignancies (time frame: During the follow-up of participant, up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020; AzTrials last refreshed its copy on 26 Oct 2026.