Status:
ACTIVE_NOT_RECRUITING
ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
Lead Sponsor:
Theravia
Collaborating Sponsors:
International Clinical Trials Association
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
2+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2025
Estimated Enrollment :
2093 Patients enrolled
Trial Details
Trial ID
NCT04707235
Start Date
August 21 2020
End Date
August 21 2025
Last Update
August 27 2024
Active Locations (87)
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1
Amiens - Picardie Hospital Adults
Amiens, France, 80054
2
Amiens Picardie Hospital Children
Amiens, France, 80054
3
Clinique de l'Europe Amiens
Amiens, France
4
Angers Hospital Adults
Angers, France, 49933