European Sickle Cell Disease Cohort - Hydroxyurea

NCT02516579 | Completed Results DMC

• 1 other identifier: ESCORT-HU
• Study Type: observational
• Target: 1,906
• Locations: 6 countries
• Sites: 19

Brief 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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• % of Patient-years With Malignancies

  During the follow-up of participant, up to 10 years

• % of Patient-years With Skin Ulcerations

  Patients with at least one skin ulceration

  During the follow-up of participant, up to 10 years

• % of Patient-years With Myelosuppressions

  Patients with at least one myelosuppression

  During the follow-up of participant, up to 10 years

Interventions

Siklos DRUG

Also known as: hydrocarbamide

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with sickle-cell disease

You may qualify if:

• 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.

Sponsors & Collaborators

• Theravia: lead

Study Sites (60)

CHU d'Amiens - Picardie - Site sud

Amiens, France

Location

Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie

Aulnay-sous-Bois, 93602, France

Location

Hôpital Avicenne; médecine interne

Bobigny, 93009, France

Location

Hôpital Jean Verdier; médecine interne

Bondy, 93143, France

Location

Hôpital Jean Verdier; pédiatrie

Bondy, 93143, France

Location

CHU Bordeaux, urgences pédiatriques

Bordeaux, 33000, France

Location

Hôpital Saint-André

Bordeaux, France

Location

CHU Estaing, pédiatrie

Clermont-Ferrand, 63003, France

Location

Hôpital Louis Mourier; pédiatrie

Colombes, 92700, France

Location

Hôpital Louis Mourier; service de pédiatrie

Colombes, 92700, France

Location

Centre hospitalier intercommunal de Créteil

Créteil, 94010, France

Location

Hôpital Henri Mondor, centre de la Drépanocytose

Créteil, 94010, France

Location

Centre Hospitalier de Gonesse, médecine interne

Gonesse, 95500, France

Location

Centre Hospitalier de Gonesse, pédiatrie

Gonesse, 95500, France

Location

CHU de Grenoble, hôpital Couple Enfant

Grenoble, 38700, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de Limoges

Limoges, France

Location

Hôpital Mère-Enfant

Limoges, France

Location

Hôpital Edouard Herriot, hémovigilance

Lyon, 69003, France

Location

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, 69373, France

Location

CHU Timone

Marseille, 13385, France

Location

Hôpital de la Conception, médecine interne

Marseille, 13385, France

Location

Centre Hospitalier Intercommunal André Grégoire

Montreuil, 93100, France

Location

CHU Nantes, Hôpital Hôtel Dieu

Nantes, 44093, France

Location

Hôpital Trousseau; pédiatrie générale

Paris, 75012, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Necker enfants, maladies infectieuses et tropicales

Paris, 75015, France

Location

Hôpital Necker; biothérapie

Paris, 75015, France

Location

Hôpital Necker; maladies infectieuses et tropicales

Paris, 75015, France

Location

Hôpital Robert Debré, immunologie-hématologie pédiatrique

Paris, 75935, France

Location

CHR Reims, American Memorial Hospital

Reims, 51100, France

Location

CHU Rennes, Hôpital Pontchaillou

Rennes, 35033, France

Location

CHU Rennes, hôpital Sud

Rennes, 35203, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Centre Hospitalier Delafontaine, médecine interne

Saint-Denis, 93205, France

Location

Centre Hospitalier Delafontaine, pédiatrie

Saint-Denis, 93205, France

Location

CHRU Strasbourg, Hôpital de Hautepierre

Strasbourg, 67098, France

Location

CHU Toulouse; hôpital des enfants

Toulouse, 31059, France

Location

Institut Universitaire du cancer; médecine interne

Toulouse, 31059, France

Location

CHU Nancy, Brabois enfants

Vandœuvre-lès-Nancy, 54511, France

Location

CH André Rosemon

Cayenne, 97306, French Guiana

Location

CMCK

Kourou, 97387, French Guiana

Location

CH Ouest Guyanais

Saint-Laurent-du-Maroni, 97320, French Guiana

Location

Charité-Universitätsmedizin, Berlin

Berlin, Germany

Location

Pädiatrie Klinikum Delmenhorst

Delmenhorst, Germany

Location

Heinrich-Heine Universität Düsseldorf

Düsseldorf, Germany

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

München

München, Germany

Location

Laiko General Hospital

Athens, Greece

Location

CH Basse-Terre, adultes

Basse-Terre, 97100, Guadeloupe

Location

CH Basse-Terre, enfants

Basse-Terre, 97100, Guadeloupe

Location

CHU Pointe à Pitre

Pointe-à-Pitre, 97159, Guadeloupe

Location

Clinica Pediatrica AOU

Napoli, Italy

Location

Azienda Ospedaliera-University of Padova

Padua, Italy

Location

Azienda Ospedaliera Universitaria Integrata (AOUI Verona)

Verona, Italy

Location

CHU Fort de France

Fort-de-France, 97200, Martinique

Location

Hôpital Pierre Zobda-Quitman

Fort-de-France, Martinique

Location

CH Lamentin

Le Lamentin, 97232, Martinique

Location

Related Publications (2)

• 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.

  PMID: 38247384 DERIVED

• 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.

  PMID: 34224583 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Medical director
• Organization: Addmedica

corinne.duguet@addmedica.com

+33172690186

Study Officials

• Frédéric Galacteros, MD

  Hôpital henri Mondor (Adults)

  PRINCIPAL INVESTIGATOR

• Mariane de Montalembert, MD

  Hôpital Necker Enfants Malades (Children)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 6, 2015
• Study Start: January 1, 2009
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

GU (3); MA (3); IT (3); DE (6); FR (3); GR (1)