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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00850369
Eligibility Criteria:
Inclusion Criteria:
1. diagnosis of sickle cell anemia (HbSS) and HbSbeta0 thalassemia;
2. male and female subjects between 18 and 65 years;
3. documented PHT, but with pulmonary artery systolic pressures \>/= 45 mmHg (TR jet velocity of \>/= 3.0 m/s) on at least 2 separate visits at least 1 month apart;
4. ability to give written informed consent to participate in the study; and
5. in non-crisis steady state at time of enrollment
Exclusion Criteria:
1. treatment with epoprostenol (flolan) or similar prostacyclin analog, bosentan or sildenafil (or similar phosphodiesterase 5 inhibitor)
2. on chronic anticoagulation
3. RBC transfusion in previous 90 days;
4. use of hydroxyurea
5. multiple red cell alloantibodies that will make transfusion unsafe;
6. baseline ferritin level \> 1000 mg/dL
7. pregnancy, and/or any condition which in the opinion of investigator might make the subject unsuitable for the study;
8. patients with WHO functional class IV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00850369
Study Brief:
Protocol Section:
NCT00850369