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European Sickle Cell Disease Cohort - Hydroxyurea (ESCORT-HU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02516579
Recruitment Status : Completed
First Posted : August 6, 2015
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
ADDMEDICA SASA

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.

Condition or disease Intervention/treatment
Sickle Cell Disease Drug: Siklos

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Study Type : Observational
Actual Enrollment : 1928 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
Study Start Date : January 2009
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea


Intervention Details:
  • Drug: Siklos
    Other Name: hydrocarbamide


Primary Outcome Measures :
  1. Occurence of adverse events and serious adverse events, specifically: - Frequency of maligancies - Frequency of skin ulceration (broken out by severity) - Frequency of myelosuppression requiring temporary or permanent discontinuation of Siklos [ Time Frame: up to 1 year follow-up ]

Secondary Outcome Measures :
  1. Effects of Siklos on growth development: specific examinations (scintigraphy, radiography,...) if the difference with the normal growth is upper than 2 standard deviations [ Time Frame: up to 1 year follow-up ]
  2. Outcome of pregnancies: rates of miscarriage, stillbirths, APGAR score at birth, congenital malformations [ Time Frame: up to 1 year follow-up ]
  3. Any occurrence of an unforeseen safety pattern [ Time Frame: up to 1 year follow-up ]

Other Outcome Measures:
  1. Overall mortality and survival rates [ Time Frame: up to 1 year follow-up ]
  2. Frequency of vaso-occlusive complications (painful crises, acute chest syndrome, stroke, acute splenic sequestration and infections) [ Time Frame: up to 1 year follow-up ]
  3. Hospitalisation due to SCD events [ Time Frame: up to 1 year follow-up ]
  4. Frequency of blood transfusions [ Time Frame: up to 1 year follow-up ]


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with sickle-cell disease
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516579


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Locations
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France
CHU d'Amiens - Picardie - Site sud
Amiens, France
Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie
Aulnay-sous-Bois, France, 93602
Hôpital Avicenne; médecine interne
Bobigny, France, 93009
Hôpital Jean Verdier; médecine interne
Bondy, France, 93143
Hôpital Jean Verdier; pédiatrie
Bondy, France, 93143
CHU Bordeaux, urgences pédiatriques
Bordeaux, France, 33000
Hôpital Saint-André
Bordeaux, France
CHU Estaing, pédiatrie
Clermont Ferrand, France, 63003
Hôpital Louis Mourier; pédiatrie
Colombes, France, 92700
Hôpital Louis Mourier; service de pédiatrie
Colombes, France, 92700
Centre hospitalier intercommunal de Créteil
Créteil, France, 94010
Hôpital Henri Mondor, centre de la Drépanocytose
Créteil, France, 94010
Centre Hospitalier de Gonesse, médecine interne
Gonesse, France, 95500
Centre Hospitalier de Gonesse, pédiatrie
Gonesse, France, 95500
CHU de Grenoble, hôpital Couple Enfant
Grenoble, France, 38700
CHU de Grenoble
Grenoble, France
CHU de Limoges
Limoges, France
Hôpital Mère-Enfant
Limoges, France
Hôpital Edouard Herriot, hémovigilance
Lyon, France, 69003
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69373
CHU Timone
Marseille, France, 13385
Hôpital de la Conception, médecine interne
Marseille, France, 13385
Centre Hospitalier Intercommunal André Grégoire
Montreuil-sous-Bois, France, 93100
CHU Nantes, Hôpital Hôtel Dieu
Nantes, France, 44093
Hôpital Trousseau; pédiatrie générale
Paris, France, 75012
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Necker enfants, maladies infectieuses et tropicales
Paris, France, 75015
Hôpital Necker; biothérapie
Paris, France, 75015
Hôpital Necker; maladies infectieuses et tropicales
Paris, France, 75015
Hôpital Robert Debré, immunologie-hématologie pédiatrique
Paris, France, 75935
CHR Reims, American Memorial Hospital
Reims, France, 51100
CHU Rennes, Hôpital Pontchaillou
Rennes, France, 35033
CHU Rennes, hôpital Sud
Rennes, France, 35203
CHU Charles Nicolle
Rouen, France, 76000
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Centre Hospitalier Delafontaine, médecine interne
Saint-Denis, France, 93205
Centre Hospitalier Delafontaine, pédiatrie
Saint-Denis, France, 93205
CHRU Strasbourg, Hôpital de Hautepierre
Strasbourg, France, 67098
CHU Toulouse; hôpital des enfants
Toulouse, France, 31059
Institut Universitaire du cancer; médecine interne
Toulouse, France, 31059
CHU Nancy, Brabois enfants
Vandoeuvre-lès-Nancy, France, 54511
French Guiana
CH André Rosemon
Cayenne, French Guiana, 97306
CMCK
Kourou, French Guiana, 97387
CH Ouest Guyanais
Saint Laurent du Maroni, French Guiana, 97320
Germany
Charité-Universitätsmedizin, Berlin
Berlin, Germany
Pädiatrie Klinikum Delmenhorst
Delmenhorst, Germany
Heinrich-Heine Universität Düsseldorf
Düsseldorf, Germany
University of Freiburg
Freiburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
München
München, Germany
Greece
Laiko General Hospital
Athens, Greece
Guadeloupe
CH Basse-Terre, adultes
Basse-Terre, Guadeloupe, 97100
CH Basse-Terre, enfants
Basse-Terre, Guadeloupe, 97100
CHU Pointe à Pitre
Pointe-à-Pitre, Guadeloupe, 97159
Italy
Clinica Pediatrica AOU
Napoli, Italy
Azienda Ospedaliera-University of Padova
Padova, Italy
Azienda Ospedaliera Universitaria Integrata (AOUI Verona)
Verona, Italy
Martinique
CHU Fort de France
Fort de France, Martinique, 97200
Hôpital Pierre Zobda-Quitman
Fort de France, Martinique
CH Lamentin
Le Lamentin, Martinique, 97232
Sponsors and Collaborators
ADDMEDICA SASA
Investigators
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Principal Investigator: Frédéric Galacteros, MD Hôpital henri Mondor (Adults)
Principal Investigator: Mariane de Montalembert, MD Hôpital Necker Enfants Malades (Children)

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Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT02516579     History of Changes
Other Study ID Numbers: ESCORT-HU
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors