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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00001958
Eligibility Criteria:
Beta-Thalassemia Intermedia patients.
Steady-state Hb values greater than 6.5gm/dl (unrelated to transfusion)
Males and females.
Patients greater than 15 years of age.
Patients who are transfusion-requiring but not dependent will be offered the opportunity to enroll.
Stable renal and hepatic function
Willingness to use appropriate birth control measures.
Ability to give informed consent.
No beta-thalassemia major.
No blood transfusion requirement greater than 1 unit every 2 months over the last 12 months.
No patients with WBC less than 4000/micrograms.
No one with a platelet count less than 150,000/micrograms.
No evidence of active viral infective, including viral hepatitis.
No abnormal liver function test (ALT or AST greater than 2.5 x normal).
No abnormal renal function test (creatinine greater 1.5 mg/dl).
No HIV positive blood test.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001958
Study Brief:
Protocol Section:
NCT00001958