Status:
UNKNOWN
Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Acquired Aplastic Anemia
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
The analysis of our own clinical data suggests that majority of the hematologic responses observed after the course of h-ATG/CsA is partial, and about 10% tend to have cyclosporine dependence. The ai...
Detailed Description
This trial will evaluate safety and efficacy of combination eltrombopag with standard hATG/CSA as first line therapy in patients with SAA. The primary endpoint is going to be estimating the rate of co...
Eligibility Criteria
Inclusion
- Clinical diagnosis of severe and very severe Aplastic anemia
- 2 - 18 years old
- Written informed consent signed by a parent or legal guardian prior to initiation of any study specific procedure.
- Absence of HLA-identical family member
Exclusion
- 1\. myelodysplastic syndrome 4. Prior immunosuppressive therapy 5. Patients with hepatic, renal or cardiac failure, or any other life- threatening concurrent disease 6. hypersensitivity to any of the component medications 7. Creatinine \>2.5 mg/dL× the upper limit of normal, 8. Total bilirubin \>1.5 × the upper limit of normal mg/dL , 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3-5 × the upper limit of normal
Key Trial Info
Start Date :
December 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03413306
Start Date
December 10 2016
End Date
October 20 2022
Last Update
March 15 2021
Active Locations (1)
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1
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117198