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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01891994
Eligibility Criteria:
* INCLUSION CRITERIA:
* Previous diagnosis of refractory severe aplastic anemia and following at least one treatment course of immunosuppression with a regimen containing antithymocyte globulin, alemtuzumab or cyclophosphamide.
* One or more of the following three clinically-significant cytopenias: platelet count less than or equal to 30,000/micro L or platelet-transfusion-dependence (requiring at least 4 platelet transfusions in the 8 weeks prior to study entry); neutrophil count less than 500/micro L; hemoglobin less than 9.0 g/dL or red cell transfusion-dependence (requiring at least 4 units of PRBCs in the eight weeks prior to study entry)
* Age greater than or equal to 2 years old
* Weight \> 12 kg
EXCLUSION CRITERIA:
* Infection not adequately responding to appropriate therapy
* Evidence of a clonal disorder on cytogenetics performed within 12 weeks of study entry.
* Creatinine \> 2.5 mg/dL
* Direct Bilirubin \> 2.0 mg/dL
* SGOT or SGPT \>5 times the upper limit of normal
* Hypersensitivity to eltrombopag or its components\<TAB\>
* Female subjects who are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
* Unable to understand the investigational nature of the study or give informed consent
* Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely
* Treatment with ATG, cyclophophamide or alemtuzamab within 6 months of study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
100 Years
Study:
NCT01891994
Study Brief:
Protocol Section:
NCT01891994