European Sickle Cell Disease Cohort - Hydroxyurea

NCT ID: NCT02516579

Last Updated: 2020-03-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1906 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2019-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Siklos

Intervention Type DRUG

Other Intervention Names

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hydrocarbamide

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theravia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Galacteros, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital henri Mondor (Adults)

Mariane de Montalembert, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Necker Enfants Malades (Children)

Locations

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CHU d'Amiens - Picardie - Site sud

Amiens, , France

Site Status

Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie

Aulnay-sous-Bois, , France

Site Status

Hôpital Avicenne; médecine interne

Bobigny, , France

Site Status

Hôpital Jean Verdier; médecine interne

Bondy, , France

Site Status

Hôpital Jean Verdier; pédiatrie

Bondy, , France

Site Status

CHU Bordeaux, urgences pédiatriques

Bordeaux, , France

Site Status

Hôpital Saint-André

Bordeaux, , France

Site Status

CHU Estaing, pédiatrie

Clermont-Ferrand, , France

Site Status

Hôpital Louis Mourier; pédiatrie

Colombes, , France

Site Status

Hôpital Louis Mourier; service de pédiatrie

Colombes, , France

Site Status

Centre hospitalier intercommunal de Créteil

Créteil, , France

Site Status

Hôpital Henri Mondor, centre de la Drépanocytose

Créteil, , France

Site Status

Centre Hospitalier de Gonesse, médecine interne

Gonesse, , France

Site Status

Centre Hospitalier de Gonesse, pédiatrie

Gonesse, , France

Site Status

CHU de Grenoble, hôpital Couple Enfant

Grenoble, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

CHU de Limoges

Limoges, , France

Site Status

Hôpital Mère-Enfant

Limoges, , France

Site Status

Hôpital Edouard Herriot, hémovigilance

Lyon, , France

Site Status

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, , France

Site Status

CHU Timone

Marseille, , France

Site Status

Hôpital de la Conception, médecine interne

Marseille, , France

Site Status

Centre Hospitalier Intercommunal André Grégoire

Montreuil, , France

Site Status

CHU Nantes, Hôpital Hôtel Dieu

Nantes, , France

Site Status

Hôpital Trousseau; pédiatrie générale

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Hôpital Necker enfants, maladies infectieuses et tropicales

Paris, , France

Site Status

Hôpital Necker; biothérapie

Paris, , France

Site Status

Hôpital Necker; maladies infectieuses et tropicales

Paris, , France

Site Status

Hôpital Robert Debré, immunologie-hématologie pédiatrique

Paris, , France

Site Status

CHR Reims, American Memorial Hospital

Reims, , France

Site Status

CHU Rennes, Hôpital Pontchaillou

Rennes, , France

Site Status

CHU Rennes, hôpital Sud

Rennes, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

CHU de Rouen - Hôpital Charles Nicolle

Rouen, , France

Site Status

Centre Hospitalier Delafontaine, médecine interne

Saint-Denis, , France

Site Status

Centre Hospitalier Delafontaine, pédiatrie

Saint-Denis, , France

Site Status

CHRU Strasbourg, Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHU Toulouse; hôpital des enfants

Toulouse, , France

Site Status

Institut Universitaire du cancer; médecine interne

Toulouse, , France

Site Status

CHU Nancy, Brabois enfants

Vandœuvre-lès-Nancy, , France

Site Status

CH André Rosemon

Cayenne, , French Guiana

Site Status

CMCK

Kourou, , French Guiana

Site Status

CH Ouest Guyanais

Saint-Laurent-du-Maroni, , French Guiana

Site Status

Charité-Universitätsmedizin, Berlin

Berlin, , Germany

Site Status

Pädiatrie Klinikum Delmenhorst

Delmenhorst, , Germany

Site Status

Heinrich-Heine Universität Düsseldorf

Düsseldorf, , Germany

Site Status

University of Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

München

München, , Germany

Site Status

Laiko General Hospital

Athens, , Greece

Site Status

CH Basse-Terre, adultes

Basse-Terre, , Guadeloupe

Site Status

CH Basse-Terre, enfants

Basse-Terre, , Guadeloupe

Site Status

CHU Pointe à Pitre

Pointe-à-Pitre, , Guadeloupe

Site Status

Clinica Pediatrica AOU

Napoli, , Italy

Site Status

Azienda Ospedaliera-University of Padova

Padua, , Italy

Site Status

Azienda Ospedaliera Universitaria Integrata (AOUI Verona)

Verona, , Italy

Site Status

CHU Fort de France

Fort-de-France, , Martinique

Site Status

Hôpital Pierre Zobda-Quitman

Fort-de-France, , Martinique

Site Status

CH Lamentin

Le Lamentin, , Martinique

Site Status

Countries

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France French Guiana Germany Greece Guadeloupe Italy Martinique

References

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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.

Reference Type DERIVED
PMID: 38247384 (View on PubMed)

de 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.

Reference Type DERIVED
PMID: 34224583 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ESCORT-HU

Identifier Type: -

Identifier Source: org_study_id

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