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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

Tracking Information
First Submitted Date July 23, 2015
First Posted Date August 6, 2015
Results First Submitted Date February 18, 2020
Results First Posted Date March 19, 2020
Last Update Posted Date March 19, 2020
Study Start Date January 2009
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
  • % of Patient-years With Malignancies [ Time Frame: 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
  • % of Patient-years With Myelosuppressions [ Time Frame: During the follow-up of participant, up to 10 years ]
    Patients with at least one myelosuppression
Original Primary Outcome Measures
 (submitted: August 5, 2015)		 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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: August 5, 2015)
  • 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 ]
  • Outcome of pregnancies: rates of miscarriage, stillbirths, APGAR score at birth, congenital malformations [ Time Frame: up to 1 year follow-up ]
  • Any occurrence of an unforeseen safety pattern [ Time Frame: up to 1 year follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 5, 2015)
  • Overall mortality and survival rates [ Time Frame: up to 1 year follow-up ]
  • Frequency of vaso-occlusive complications (painful crises, acute chest syndrome, stroke, acute splenic sequestration and infections) [ Time Frame: up to 1 year follow-up ]
  • Hospitalisation due to SCD events [ Time Frame: up to 1 year follow-up ]
  • Frequency of blood transfusions [ Time Frame: up to 1 year follow-up ]
 
Descriptive Information
Brief Title European Sickle Cell Disease Cohort - Hydroxyurea
Official Title ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with sickle-cell disease
Condition Sickle Cell Disease
Intervention Drug: Siklos
Other Name: hydrocarbamide
Study Groups/Cohorts Not Provided
Publications * de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galacteros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2020)		 1906
Original Estimated Enrollment
 (submitted: August 5, 2015)		 2000
Actual Study Completion Date March 20, 2019
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   French Guiana,   Germany,   Greece,   Guadeloupe,   Italy,   Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT02516579
Other Study ID Numbers ESCORT-HU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party ADDMEDICA SASA
Original Responsible Party Same as current
Current Study Sponsor ADDMEDICA SASA
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Frédéric Galacteros, MD Hôpital henri Mondor (Adults)
Principal Investigator: Mariane de Montalembert, MD Hôpital Necker Enfants Malades (Children)
PRS Account ADDMEDICA SASA
Verification Date March 2020