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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT02225132
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age greater than or equal to 15 years
2. Homozygous sickle cell disease (HbSS)
3. Patients with recent transfusion must have HbA \<15% prior to enrollment
4. ANC greater than or equal to 2,000/microL, platelets greater than or equal to150,000/microL, Hb \> 5.4g/dL, and ARC greater than or equal to100,000/microL (unless the Hb is \> 8g/dL) at baseline
5. Patients on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers should be on a stable dose for 2 weeks prior to initiating or adjusting HU
EXCLUSION CRITERIA:
1. Pregnant or lactating women or patients planning to get pregnant during the study period
2. Patients unwilling to use two forms of contraception throughout the period of HU administration
3. Patients receiving chronic transfusion therapy
4. Patients receiving a HU dose of greater than or equal to 20 mg/kg/day
5. Patients with history of allergy or intolerance to HU judged by the investigator to be prohibitive against restarting HU
6 Patients with end stage renal disease defined as GFR \<10mL/min/1.73m(2)
7\. Patients being treated with antiretroviral agents (such as didanosine and stavudine) because of a higher risk for potentially fatal pancreatitis, hepatic failure, hepatitis, and severe peripheral neuropathy when co-administered with hydroxyurea.
8\. Participation on any other chronic investigative treatment studies
9\. Unable to understand the investigational nature of the study or give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
99 Years
Study:
NCT02225132
Study Brief:
Protocol Section:
NCT02225132