|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02516579 |
|
Date of registration:
|
23/07/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
European Sickle Cell Disease Cohort - Hydroxyurea
ESCORT-HU |
|
Scientific title:
|
ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
1906 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02516579 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
|
French Guiana
|
Germany
|
Greece
|
Guadeloupe
|
Italy
|
Martinique
| |
|
Contacts
|
|
Name:
|
Frédéric Galacteros, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hôpital henri Mondor (Adults) |
|
|
Name:
|
Mariane de Montalembert, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hôpital Necker Enfants Malades (Children) |
| |
|
Key inclusion & exclusion 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.
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Sickle Cell Disease
|
|
Intervention(s)
|
|
Drug: Siklos
|
|
Primary Outcome(s)
|
|
% of Patient-years With Malignancies
[Time Frame: 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]
|
|
% of Patient-years With Skin Ulcerations
[Time Frame: During the follow-up of participant, up to 10 years]
|
|
Secondary ID(s)
|
|
ESCORT-HU
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|