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

March 5, 2020 updated by: ADDMEDICA SASA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1906

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with sickle-cell disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of Patient-years With Malignancies
Time Frame: During the follow-up of participant, up to 10 years
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
During the follow-up of participant, up to 10 years
% of Patient-years With Myelosuppressions
Time Frame: During the follow-up of participant, up to 10 years
Patients with at least one myelosuppression
During the follow-up of participant, up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADDMEDICA SASA

Investigators

  • Principal Investigator: Frédéric Galacteros, MD, Hôpital henri Mondor (Adults)
  • Principal Investigator: Mariane de Montalembert, MD, Hôpital Necker Enfants Malades (Children)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCORT-HU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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