Status:
COMPLETED
Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia
Lead Sponsor:
Assiut University
Conditions:
Eltrombopag
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
Aplastic anemia is a rare disorder characterized by pancytopenia and a hypo cellular bone marrow.but,It is very serious disease causing morbidity and mortality. Aplastic anemia can be treated effecti...
Detailed Description
Aplastic anemia is a rare disorder characterized by pancytopenia and a hypo cellular bone marrow.This causes a deficiency of all three blood cell types (pancytopenia): red blood cells (anemia), white ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03243656
Start Date
December 20 2017
End Date
January 5 2020
Last Update
January 18 2022
Active Locations (1)
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1
Facility of medicine
Asyut, Egypt, 71511