Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04707235
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT04707235
Study Brief:
Protocol Section:
NCT04707235