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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03401112
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female participants with confirmed SCA
* Age 18 to 55 years, inclusive
* For participants on HU, must have been on a stable dose for at least 60 days prior to screening
Key Exclusion Criteria:
* Total hemoglobin \>12.5 or \<6 grams/deciliter
* Red blood cell transfusion within 60 days of baseline
* \>7 hospitalizations for vaso-occlusive crises (VOCs) within the last year
* Estimated glomerular filtration rate \<50 milliliter/minute
* Aspartate aminotransferase/alanine aminotransferase \>3x the upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03401112
Study Brief:
Protocol Section:
NCT03401112