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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00005934
Eligibility Criteria:
INCLUSION CRITERIA:
Thalassemia major with progressive disease or complications of iron overload despite traditional transfusion and iron chelation therapy
Thalassemia major in which standard transfusion therapy or iron chelation therapy is contraindicated
ECOG performance status must be less than or equal to 2
NYHA less than or equal to class II status
Progressive disease is defined as 1) an increasing transfusion requirement or difficulty in maintenance of hemoglobin levels greater than 7g/dl as a consequence of autologous or allogeneic antibodies or 2) increasing extramedullary hematopoiesis causing compression phenomena.
Complications of iron overload despite iron chelation therapy is defined as difficulty in achieving negative iron balance when complications of iron overload exist. Complications of iron overload include heart failure, or decreased cardiac ejection fraction, endocrinopathy and evidence of progressive liver dysfunction.
EXCLUSION CRITERIA:
Severe sepsis or septic shock
Current pregnancy or breast feeding
Not able to give informed consent
Altered mental status or seizure disorder
AST or ALT greater than 3X upper limit of normal
Bilirubin greater than1.5X upper limit of normal, unless the abnormal bilirubin can be accounted for by indirect hyperbilirubinemia due to hemolysis or Gilbert's Disease
Serum albumin less than 3g/dl
Creatinine greater than 2mg/dl and creatinine clearance less than 60ml/min
Patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 7-10 days is likely
Concurrent myelodysplastic syndrome or leukemia
NYHA class III/IV status
ECOG performance status greater than 2
Age less than 18 years
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00005934
Study Brief:
Protocol Section:
NCT00005934