ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

June 14, 2023 updated by: ADDMEDICA SASA

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension

As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • Amiens - Picardie Hospital Adults
        • Contact:
        • Principal Investigator:
          • Loïc Garçon
        • Sub-Investigator:
          • Lavinia Merlusca
      • Amiens, France, 80054
        • Recruiting
        • Amiens Picardie Hospital Children
        • Contact:
        • Principal Investigator:
          • Valérie Li Thiao Te
      • Amiens, France
        • Not yet recruiting
        • Clinique de l'Europe Amiens
        • Principal Investigator:
          • Réda GARIDI
        • Contact:
      • Angers, France, 49933
        • Active, not recruiting
        • Angers Hospital Adults
      • Angers, France, 49933
        • Recruiting
        • Angers Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Jean François Brasme
        • Sub-Investigator:
          • Isabelle Pellier
      • Aulnay-sous-Bois, France, 93602
        • Active, not recruiting
        • Robert Ballanger Hospital Adults
      • Aulnay-sous-Bois, France, 93602
        • Recruiting
        • Robert Ballanger Hospital Children
        • Contact:
        • Principal Investigator:
          • Marie Belloy
        • Sub-Investigator:
          • Julie Durin
        • Sub-Investigator:
          • Donald Celicourt
        • Sub-Investigator:
          • Anne Farge
      • Bobigny, France, 93009
        • Recruiting
        • Avicenne Hospital Adults
        • Principal Investigator:
          • Sylvain Le Jeune
        • Contact:
        • Sub-Investigator:
          • Marilucy Lopez Sublet
        • Sub-Investigator:
          • Antonio Morabito
      • Bondy, France, 93143
        • Recruiting
        • Jean Verdier Hospital Children
        • Contact:
        • Principal Investigator:
          • Patricia Benhaïm
        • Sub-Investigator:
          • Lahoueri Amor Chelihi
      • Bordeaux, France, 33000
        • Recruiting
        • Bordeaux Hospital Children
        • Contact:
        • Principal Investigator:
          • Camille Runel-Belliard
        • Sub-Investigator:
          • Marie Lagarde
      • Bordeaux, France, 33000
        • Recruiting
        • Bordeaux Hospital Adults
        • Contact:
        • Principal Investigator:
          • Arnaud Desclaux
        • Sub-Investigator:
          • Thierry Pistone
        • Sub-Investigator:
          • Alexandre Duvignaud
        • Sub-Investigator:
          • Denis Malvy
        • Sub-Investigator:
          • Duc Nguyen
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Ambroise Paré Hospital Children
        • Contact:
        • Principal Investigator:
          • Valérie Soussan Banini
      • Chambray-lès-Tours, France, 37170
        • Recruiting
        • Tours Regional University Hospital Center Adults
        • Contact:
        • Principal Investigator:
          • Jean Baptiste Valentin
        • Sub-Investigator:
          • Laurent Ardillon
      • Clermont-Ferrand, France, 63003
        • Active, not recruiting
        • Estaing Hospital Children
      • Colombes, France, 92700
        • Recruiting
        • Louis Mourier Hospital Adults
        • Contact:
        • Principal Investigator:
          • Louis Mourier
      • Colombes, France, 92700
        • Recruiting
        • Louis Mourier Hospital Children
        • Contact:
        • Principal Investigator:
          • Romain Basmaci
        • Sub-Investigator:
          • Nevena Danekova
        • Principal Investigator:
          • Hélène See
      • Corbeil-Essonnes, France
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
        • Principal Investigator:
          • Cécile Guillaumat
        • Sub-Investigator:
          • Bérénice Chailloux Mirat
        • Sub-Investigator:
          • Guillaume Costa
        • Sub-Investigator:
          • Melek Djaziri
      • Corbeil-Essonnes, France, 91100
        • Recruiting
        • Sud Francilien Hospital Center Adults
        • Contact:
        • Sub-Investigator:
          • Célia Salanoubat
        • Principal Investigator:
          • Elsa Ngwem
      • Creil, France, 60100
        • Not yet recruiting
        • Sud Oise Public Hospital Group Adults
        • Contact:
        • Principal Investigator:
          • Sai Atmani
      • Créteil, France, 94010
        • Recruiting
        • Intercommunal Hospital Center of Créteil Adults and Children
        • Principal Investigator:
          • Corinne Pondarré
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Isabelle Genty
        • Sub-Investigator:
          • Cécile Arnaud
        • Principal Investigator:
          • Annie Kamdem
      • Créteil, France, 94010
        • Recruiting
        • Henri Mondor Hospital Adults
        • Principal Investigator:
          • Frédéric Galactéros
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pablo Bartolucci
        • Sub-Investigator:
          • Gonzalo De Luna Cardenal
        • Sub-Investigator:
          • Anoosha Habibi
        • Sub-Investigator:
          • Elena Foïs
        • Sub-Investigator:
          • Suella Martino
      • Dreux, France, 28102
        • Recruiting
        • Dreux Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Désiré Ndayarinze
      • Gonesse, France, 95500
        • Recruiting
        • Gonesse Hospital Children
        • Contact:
        • Principal Investigator:
          • Michel Benemou
        • Sub-Investigator:
          • Alexandra Lazarevic
        • Sub-Investigator:
          • Mayssa Sarakbi
      • Jossigny, France, 77600
        • Recruiting
        • Marne-La-Vallée Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Nathalie Garrec
        • Sub-Investigator:
          • Kokou Agbo kpati
      • La Tronche, France, 38700
        • Recruiting
        • Grenoble Hospital Adults
        • Contact:
        • Principal Investigator:
          • Caroline Makowski
        • Sub-Investigator:
          • Laurence Bouillet
        • Sub-Investigator:
          • Alexis Bocquet
      • La Tronche, France, 38700
        • Recruiting
        • Grenoble Hospital Children
        • Contact:
        • Principal Investigator:
          • Corinne Armari Alla
        • Sub-Investigator:
          • cécile perret
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre
        • Principal Investigator:
          • Corinne Guitton
        • Contact:
        • Sub-Investigator:
          • Ferielle Zenkhri
      • Le Kremlin-Bicêtre, France, 94270
      • Le Mans, France
        • Recruiting
        • CH du Mans
        • Contact:
        • Principal Investigator:
          • Vannina Giacobbi-Milet
      • Lille, France, 59037
        • Recruiting
        • Jeanne De Flandre Hospital Children
        • Contact:
        • Principal Investigator:
          • Anne Lambilliotte
        • Sub-Investigator:
          • Melissa Barbati
      • Lille, France
        • Recruiting
        • Hôpital Saint-Vincent de Paul
        • Contact:
        • Principal Investigator:
          • Benjamin Carpentier
      • Limoges, France
        • Recruiting
        • Hôpital Mère-Enfant - CHU de Limoges
        • Contact:
        • Principal Investigator:
          • Christophe PIGUET
      • Lyon, France, 69003
        • Recruiting
        • Edouard Herriot Hospital Adults
        • Contact:
        • Principal Investigator:
          • Giovanna Cannas
      • Lyon, France, 69373
        • Recruiting
        • Hematology and oncology institute Children
        • Contact:
        • Principal Investigator:
          • Alexandra Gauthier Vasserot
        • Sub-Investigator:
          • Nathalie Garnier
        • Sub-Investigator:
          • Cécile Renard
        • Sub-Investigator:
          • Carine Halfon Domenech
        • Sub-Investigator:
          • Yves Bertrand
        • Sub-Investigator:
          • Kamila Kebaili
      • Marseille, France, 13005
        • Recruiting
        • Timone Hospital Adults
        • Contact:
        • Principal Investigator:
          • Estelle Jean Mignard
        • Sub-Investigator:
          • Benoît Faucher
        • Sub-Investigator:
          • Julie Seguier
      • Marseille, France
        • Recruiting
        • Timone Hospital Children
        • Contact:
        • Principal Investigator:
          • Isabelle Thuret
        • Sub-Investigator:
          • Sarah Szepetowski
      • Meaux, France, 77100
        • Recruiting
        • Meaux Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Caroline Masserot Lureau
        • Sub-Investigator:
          • François Gouraud
        • Sub-Investigator:
          • Marie Monfort Gouraud
      • Meaux, France, 77100
        • Recruiting
        • Meaux Hospital Center Adults
        • Contact:
        • Principal Investigator:
          • Jamile Frayfer
      • Montpellier, France, 34295
        • Recruiting
        • Montpellier Hospital Children
        • Contact:
        • Principal Investigator:
          • Perrine Mahé
      • Montpellier, France, 34070
        • Recruiting
        • St Eloi Hospital Adults
        • Contact:
        • Principal Investigator:
          • Ivan Bertchansky
        • Sub-Investigator:
          • Robert Navarro
      • Mulhouse, France, 68100
        • Active, not recruiting
        • Emile Muller Hospital Adults
      • Nantes, France, 44000
        • Recruiting
        • Nantes Hospital Children
        • Contact:
        • Principal Investigator:
          • Marie Laure Couec
        • Sub-Investigator:
          • Caroline Thomas
        • Sub-Investigator:
          • Alice Huault
      • Nantes, France, 44093
        • Recruiting
        • Nantes Hospital Adults
        • Contact:
        • Principal Investigator:
          • Agathe Masseau
        • Sub-Investigator:
          • Graveleau Julie
        • Sub-Investigator:
          • Alexandra Espitia
        • Sub-Investigator:
          • Marine Eustache
      • Nice, France, 06200
        • Recruiting
        • Nice Hospital Children
        • Contact:
        • Principal Investigator:
          • Pierre Simon Rohrlich
        • Sub-Investigator:
          • Nihal Martis
        • Sub-Investigator:
          • Lionel Mannone
        • Sub-Investigator:
          • Joy Benadiba
      • Orléans, France, 45066
        • Recruiting
        • Orléans Hospital Adults
        • Principal Investigator:
          • Marie-Françoise Barrault
        • Contact:
        • Principal Investigator:
          • Hélène Bens
      • Paris, France, 75012
        • Recruiting
        • Armand Trousseau Hospital Children
        • Contact:
        • Principal Investigator:
          • Marie-Hélène Odièvre
        • Sub-Investigator:
          • Jenny Youn
        • Sub-Investigator:
          • Assa Niakate
        • Sub-Investigator:
          • Anne-Sophie Romain
      • Paris, France, 75012
        • Recruiting
        • Saint-Antoine Hospital Adults
        • Contact:
        • Principal Investigator:
          • Latifatou Boukari
        • Sub-Investigator:
          • Maria Chauchard
      • Paris, France, 75015
        • Recruiting
        • Georges Pompidou European Hospital Adults
        • Contact:
        • Principal Investigator:
          • Jean Benoît Arlet
      • Paris, France, 75015
        • Recruiting
        • Necker Hospital Adults
        • Contact:
        • Principal Investigator:
          • Laure Joseph
        • Sub-Investigator:
          • Benoît Meunier
      • Paris, France, 75015
        • Recruiting
        • Necker Hospital Children
        • Contact:
        • Principal Investigator:
          • Mariane de Montalembert
        • Sub-Investigator:
          • Melissa Taylor
        • Sub-Investigator:
          • Slimane Allali
      • Paris, France, 75019
        • Recruiting
        • Robert Debré Hospital Children
        • Contact:
        • Contact:
        • Principal Investigator:
          • Malika Benkerrou
        • Sub-Investigator:
          • Laurent Holvoet
        • Sub-Investigator:
          • Florence Missud
        • Sub-Investigator:
          • Berengere Koehl
        • Sub-Investigator:
          • Ghislaine Ithier
        • Sub-Investigator:
          • Valentine Brousse
      • Perpignan, France
        • Not yet recruiting
        • Centre Hospitalier Perpignan
        • Contact:
        • Principal Investigator:
          • Rodereau Outh
      • Poitiers, France, 86020
        • Recruiting
        • Poitiers Hospital Adults
        • Contact:
        • Principal Investigator:
          • Justine Gellen Dautremer
        • Sub-Investigator:
          • Alain Ramassamy
      • Reims, France, 51100
        • Recruiting
        • American Hospital Children
        • Principal Investigator:
          • Claire Pluchart
        • Contact:
      • Reims, France, 51100
        • Recruiting
        • Reims Hospital Adults
        • Contact:
        • Principal Investigator:
          • Violaine Laurant Noel
        • Sub-Investigator:
          • Ailsa Robbins
      • Rennes, France, 35033
      • Rouen, France, 76000
        • Recruiting
        • Charles Nicolle Hospital Adults
        • Contact:
        • Principal Investigator:
          • Maximilien Grall
        • Sub-Investigator:
          • Agnès Lahary
        • Sub-Investigator:
          • Gaetan Sauvetre
      • Rouen, France, 76000
        • Recruiting
        • Rouen Hospital Children
        • Contact:
        • Principal Investigator:
          • Cécile Dumesnil de Maricourt
        • Sub-Investigator:
          • Bruno Filhon
      • Saint-Brieuc, France, 22000
        • Recruiting
        • Yves Le Foll. Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Amélie Vareliette
      • Saint-Denis, France, 93200
        • Recruiting
        • Delafontaine Hospital Center Adults
        • Contact:
        • Principal Investigator:
          • Stéphanie Ngo
      • Saint-Denis, France, 93200
        • Recruiting
        • Delafontaine Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Aurore Malric
        • Sub-Investigator:
          • Basil Coulon
        • Sub-Investigator:
          • Laure Nizery
      • Saint-Quentin, France, 02321
        • Active, not recruiting
        • Saint-Quentin Hospital Center Adults
      • Strasbourg, France, 67098
      • Toulouse, France, 31059
        • Recruiting
        • Children Hospital
        • Contact:
        • Principal Investigator:
          • Marie Pierre Castex
        • Sub-Investigator:
          • Marie Lamant
      • Toulouse, France, 31059
        • Recruiting
        • Toulouse University Institute of cancer Adults
        • Contact:
        • Principal Investigator:
          • Pierre Cougoul
      • Tours, France, 37000
        • Recruiting
        • Clocheville Regional University Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Jill Serre
        • Sub-Investigator:
          • Mathilde Dubrasquet
      • Vandoeuvre les nancy, France, 54500
        • Recruiting
        • Nancy Hospital Children
        • Contact:
        • Principal Investigator:
          • Aurélie Phulpin
      • Versailles, France, 78157
        • Recruiting
        • Versailles Hospital Center Children
        • Contact:
        • Principal Investigator:
          • Oussama Charara
  • French Guiana
      • Cayenne, French Guiana, 97300
      • Kourou, French Guiana, 97387
        • Terminated
        • Centre hospitalier de Kourou Children
      • Saint-Laurent-du-Maroni, French Guiana, 97393
        • Not yet recruiting
        • Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults
        • Contact:
        • Principal Investigator:
          • Caroline Misslin-Tritsch
        • Principal Investigator:
          • Franklin Samou Fantcho
      • Saint-Laurent-du-Maroni, French Guiana, 97393
        • Recruiting
        • Centre Hospitalier de l'Ouest Guyanais Franck Joly Children
        • Contact:
        • Principal Investigator:
          • Tileuk Welameuk Victorine
        • Principal Investigator:
          • Narcisse Elenga
        • Sub-Investigator:
          • Archippe Muhandule Birindwa
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité Hospital Children
        • Contact:
        • Principal Investigator:
          • Lena Oevermann
        • Sub-Investigator:
          • Dani Hakimeh
      • Düsseldorf, Germany
        • Not yet recruiting
        • Düsseldorf Hospital Children
        • Contact:
        • Principal Investigator:
          • Florian Babor
        • Sub-Investigator:
          • Sonya El Amouri
      • Freiburg, Germany
        • Recruiting
        • Freiburg Hospital Children
        • Contact:
        • Principal Investigator:
          • Miriam Erlacher
        • Sub-Investigator:
          • Alexander Puzik
        • Sub-Investigator:
          • Charlotte Niemeyer
        • Sub-Investigator:
          • Sarah Salou
      • Hamburg, Germany
        • Recruiting
        • Hamburg Hospital Children
        • Contact:
        • Sub-Investigator:
          • Christina Möller-Titel
        • Principal Investigator:
          • Uwe Kordes
      • Koblenz, Germany
        • Active, not recruiting
        • Koblenz Hospital Children
  • Greece
      • Athens, Greece
        • Recruiting
        • Laiko General Hospital Adults
        • Principal Investigator:
          • Ersi Voskaridou
        • Sub-Investigator:
          • Pagona Flevari
        • Contact:
        • Principal Investigator:
          • Maria Dimopoulou
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe, 97159
        • Recruiting
        • Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children
        • Contact:
        • Principal Investigator:
          • Marie Petras
        • Sub-Investigator:
          • Lydia Divialle-Doumdo
      • Pointe-à-Pitre, Guadeloupe, 97159
        • Recruiting
        • Hôpital RICOU - CHU Pointe-à-Pitre Abymes
        • Principal Investigator:
          • Maryse Etienne-Julan
        • Contact:
        • Sub-Investigator:
          • Emmanuelle Bernit
        • Sub-Investigator:
          • Scylia Alexis-Fardini
  • Italy
      • Modena, Italy
        • Recruiting
        • AUO Policlinico di Modena
        • Contact:
        • Principal Investigator:
          • Giovanni Palazzi
        • Sub-Investigator:
          • Elena Bigi
        • Sub-Investigator:
          • Mariaelena Guerzoni
      • Napoli, Italy
        • Recruiting
        • Napoli Hospital Children
        • Contact:
        • Principal Investigator:
          • Silverio Perrotta
        • Sub-Investigator:
          • Maddalena Casale
      • Padova, Italy
        • Recruiting
        • Padova Hospital Children
        • Contact:
        • Principal Investigator:
          • Raffaella Colombatti
        • Sub-Investigator:
          • Giulia Reggiani
        • Sub-Investigator:
          • Laura Sainati
        • Sub-Investigator:
          • Maria Paola Boaro
      • Verona, Italy
        • Not yet recruiting
        • Verona Hospital Children
        • Contact:
        • Principal Investigator:
          • Simone Cesaro
        • Sub-Investigator:
          • Elisa Bonetti
        • Sub-Investigator:
          • Valentina Baretta
        • Sub-Investigator:
          • Rita Balter
  • Martinique
      • Fort-de-France, Martinique, 97261
        • Recruiting
        • CHU Fort de France Children
        • Contact:
        • Principal Investigator:
          • Katell Michaux
        • Sub-Investigator:
          • Gisèle Elana
        • Sub-Investigator:
          • Claire Dichamp
        • Sub-Investigator:
          • Hanine Mansour
        • Sub-Investigator:
          • Anne-Caroline Isidore
      • Le Lamentin, Martinique, 97232
        • Recruiting
        • CHU Martinique Adults
        • Principal Investigator:
          • Gylna Loko
        • Contact:
        • Sub-Investigator:
          • Romana Ifrim
        • Sub-Investigator:
          • Anais Bourgignon d'Herbigny
  • Réunion
      • Saint-Pierre, Réunion
        • Recruiting
        • CHU Sud Réunion
        • Contact:
        • Principal Investigator:
          • Hugo LEGENDRE
        • Sub-Investigator:
          • Patricia Zunic
        • Sub-Investigator:
          • Quentin Cabrera
        • Sub-Investigator:
          • Catherine Mohr
        • Sub-Investigator:
          • Cécile Stoven

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

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Investigators will be recruited among physicians experienced in SCD management who are the only ones authorised to initiate Siklos® treatment hence to enrol and to follow up the participants. Investigators who are already participating in ESCORT-HU study will be asked to participate in the extension study.

Patient selection will be based on a systematic sampling technique: during the recruitment period, patients fulfilling the inclusion criteria will be informed by their initiating physician about the ESCORT-HU Extension study and enrolled in case they agree to participate.

Description

Inclusion Criteria:

  • Male or female patients with symptomatic SCD,
  • ≥ 2 years old,
  • Treated with Siklos®,
  • Having been informed of the study by the investigator and consenting to participate, or whose parents or legal guardians are consenting for their child to participate.

To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:

  • Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,

  • New participants with any of the following criteria:

    • history of HU treatment for more than 5 years or
    • prepubescent over 10 years of age for girls and 13 years of age for boys at enrolment, or
    • with history of leg ulcer, or
    • pregnant women without interruption of Siklos® 3 months before the beginning of the pregnancy or,
    • males treated with Siklos® whose partner is pregnant and without discontinuation of Siklos® 3 months before the beginning of the pregnancy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sickle cell disease patients treated with Siklos
Drug: Hydroxycarbamide
Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
Other Names:
  • Hydroxyurea
  • Siklos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence and incidence of the number of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®
Time Frame: 5 years
5 years
Occurrence and incidence of the number of leg ulcers
Time Frame: 5 years
5 years
Occurrence and incidence of male fertility impairment
Time Frame: 5 years
5 years
Occurrence and incidence of serious unexpected AEs causally related to Siklos®
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean age of puberty
Time Frame: 5 years
Document changes in fertility status in males and females
5 years
Mean number of patients with the use of a contraception, incidence of the use of semen cryopreservation and of semen analysis performed
Time Frame: 5 years
Document changes in fertility status in males and females
5 years
Incidence of the use of semen cryopreservation and of semen analysis performed
Time Frame: 5 years
Document changes in fertility status in males and females
5 years
Incidence of semen analysis performed
Time Frame: 5 years
Document changes in fertility status in males and females
5 years
Management of Siklos® during pregnancy and outcome of pregnancy following exposure at the time of conception or at any time during the pregnancy
Time Frame: 5 years
Outcome of pregnancies Following exposure to Siklos® at the time of conception (in participant and participant's partner) or at any time during the pregnancy
5 years
Frequency and reason for temporary or permanent discontinuations of Siklos®
Time Frame: 5 years
Potential barriers to the compliance to the prescription of Siklos
5 years
Number of switch and combination with alternative treatment
Time Frame: 5 years
5 years
Measure of quality of life with SF12 questionnaire
Time Frame: 5 years
Quality of life for adults SCD patients
5 years

Collaborators and Investigators

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

Sponsor

ADDMEDICA SASA

Collaborators

International Clinical Trials Association

Investigators

  • Study Chair: Mariane de Montalembert, MD, PhD, Hôspital Necker Enfants Malades
  • Study Chair: Frédéric Galactéros, MD, PhD, Henri Mondor University Hospital

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 (Actual)

August 21, 2020

Primary Completion (Estimated)

August 21, 2025

Study Completion (Estimated)

August 21, 2025

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCORT-HU Extension

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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