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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
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
ADDMEDICA SASA

Study Description
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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

Study Design
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Study Type : Observational
Actual Enrollment : 1906 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


Groups and Cohorts
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Intervention Details:
  • Drug: Siklos
    Other Name: hydrocarbamide

Outcome Measures
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Primary Outcome Measures :
  1. % of Patient-years With Malignancies [ Time Frame: During the follow-up of participant, up to 10 years ]
  2. % 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

  3. % of Patient-years With Myelosuppressions [ Time Frame: During the follow-up of participant, up to 10 years ]
    Patients with at least one myelosuppression


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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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)
  Study Documents (Full-Text)

Documents provided by ADDMEDICA SASA:
Study Protocol and Statistical Analysis Plan  [PDF] October 20, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT02516579    
Other Study ID Numbers: ESCORT-HU
First Posted: August 6, 2015    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn