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Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA

NCT03413306 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-03-15

No results posted yet for this study

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 aim of the current study is to improve the rate and the quality of hematologic response as well as to prevent delayed complications such as relapse and clonal progression by means of adding eltrombopag to standard immunosuppressive therapy

Conditions

  • Acquired Aplastic Anemia

Interventions

DRUG

Eltrombopag

Eltrombopag is an oral mimetic thrombopoietin selectively binding transmembrane and juxtamembrane domains of the thrombopoietin receptor different from the binding site of thrombopoietin. Therefore it does not compete for binding with the native molecule. It is promoting thrombopoiesis and release platelets from mature megakaryocytes. Also it promotes more primitive multilineage progenitors and hematopoietic stem cells to proliferate and differentiate into thrombocytes, erythrocytes and leukocytes.

DRUG

IST (ATG + CsA)

Sponsors & Collaborators

  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Principal Investigators

  • Galina Novichkova · Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

  • Alexei Maschan · Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-10
Primary Completion
2022-10-20
Completion
2022-10-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03413306 on ClinicalTrials.gov