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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT03243656
Eligibility Criteria:
Inclusion Criteria:
Current diagnosis of sever Aplastic anemia
* Diagnosis of sever Aplastic anemia is established if Bone marrow cellularity \<25% or and at least two of the following criteria are met:- (i) absolute neutrophil count less than 0.5 × 109/L, (ii) platelet count less than 20 × 109/L, and (iii) reticulocyte count less than 20 × 109/L
* No, evidence of viral or drug suppression of the marrow, dysplasia, or underproduction anemias secondary to B12, folate, iron or other reversible causes.
* Age equal to 1 years old to 18 years old
* Written informed consent signed by a parent or legal guardian prior to initiation of any study specific procedure.
* Hematopoietic stem cell transplantation is not available or suitable as a treatment option or has been refused by the patient.
* Bone marrow aspirate and biopsy at any time during the 4 weeks prior to first dose of eltrombopag
Exclusion Criteria:
Prior and/or active medical history of:-
* Fanconi anemia (via chromosomal breakage test or growth arrest by flow cytometry). Other known underlying congenital/inherited marrow failure syndromes.
* Symptomatic Paroxysmal Nocturnal Hemoglobinuria
* Other known or suspected underlying primary immunodeficiency
* Any malignancy
* Active infection not responding to appropriate therapy
* Any out of range lab values Creatinine \>2.5 mg/dL× the upper limit of normal, Total bilirubin \>1.5 × the upper limit of normal mg/dL ,Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 × the upper limit of normal
* Hypersensitivity to eltrombopag or its components
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT03243656
Study Brief:
Protocol Section:
NCT03243656