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

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ClinicalTrials.gov Identifier: NCT02516579
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : October 11, 2018
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

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
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 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


  Show 60 Study Locations
Sponsors and Collaborators
ADDMEDICA SASA
Investigators
Principal Investigator: Frédéric Galacteros, MD Hôpital henri Mondor (Adults)
Principal Investigator: Mariane de Montalembert, MD Hôpital Necker Enfants Malades (Children)

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: October 11, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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