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 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT02850406
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants with homozygous hemoglobin SS (HbSS) or hemoglobin S beta0 thalassemia (HbS β0thal)
* Age:
* Part A - 6 to 17 years of age
* Part B - 12 to 17 years of age
* Part C - 4 to 17 years of age
* Part D - 6 months to \<4 years of age
* Hydroxyurea (HU) therapy:
* Parts A, B, and C: A participant taking hydroxyurea (HU) may be enrolled if the dose has been stable for at least 3 months with no anticipated need for dose adjustment during the study and no sign of hematological toxicity.
* Part D: A participant taking HU may be enrolled if the dose has been stable for at least 1 month. Titration to the maximum tolerated dose (MTD) is allowed during the study.
* Hemoglobin (HB):
* Part A - No restriction
* Parts B, C, \& D - Hb ≤ 10.5 g/dL
* For Part C only: Participants 12 to 17 years of age must have a TCD velocity of ≥ 140 cm/sec measured anytime during screening.
Exclusion Criteria:
* Any one of the following requiring medical attention within 14 days of signing the Informed Consent Form (ICF):
* Vaso-occlusive crisis (VOC)
* Acute chest syndrome (ACS)
* Splenic sequestration crisis
* Dactylitis
* Requires chronic transfusion therapy
* History of stroke or meeting criteria for primary stroke prophylaxis (history of two TCD measurements ≥ 200 cm/sec by non-imaging TCD or ≥185 cm/sec by TCDi).
* Transfusion within 30 days prior to signing the ICF
Exclusion Criteria for Part D Only:
* Body weight \<5 kg for 1 month prior to the screening visit and at the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT02850406
Study Brief:
Protocol Section:
NCT02850406