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:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT00056433
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Patients must have documented hemoglobin S-only, S-beta-thalassemia, or other sickle cell disease genotype. Only patients with hemoglobin S-only will be considered in the primary analysis.
2. Patients must have relatively well preserved renal and hepatic function (creatinine less than 1.6 mg/dl and normal liver function test less than 5 X normal ALT).
3. Evidence of severe sickle cell anemia will include one or more of the following: recurrent pain crisis (greater than or equal to 2 ER visits per year), recurrent acute chest syndrome (a lung problem like pneumonia), hospitalizations, leg ulceration, priapism, aseptic necrosis of the hip, and/or pulmonary hypertension.
4. Patients must be able to provide informed consent.
EXCLUSION CRITERIA:
1. Patients who have hemoglobin S and A (trait) or hemoglobin A-only (non-sickle cell).
2. Patients must not be on a chronic transfusion program, defined as regular transfusions every 2-8 weeks.
3. Patients must not be pregnant or breast feeding.
4. Patients on chronic nitrates, such as nitroglycerin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00056433
Study Brief:
Protocol Section:
NCT00056433