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NCT03413306

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

Status unknown Phase 3 Last updated 15 March 2021
What this trial tests

Phase 3 trial testing Eltrombopag in Acquired Aplastic Anemia in 100 participants. Status unknown.

Timeline
10 December 2016
Primary endpoint
20 October 2022
20 October 2022

Quick facts

Lead sponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment100
Start date10 December 2016
Primary completion20 October 2022
Estimated completion20 October 2022
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 2 to 18, any sex, with Acquired Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Activity of eltrombopag in severe aplastic anemia.
    Scheinberg P. · · 2018 · cited 31× · PMID 30425070 · DOI 10.1182/bloodadvances.2018020248
  2. Efficacy of combined immunosuppression with or without eltrombopag in children with newly diagnosed aplastic anemia.
    Goronkova O, Novichkova G, Salimova T, Kalinina I, et al · · 2023 · cited 24× · PMID 35446936 · DOI 10.1182/bloodadvances.2021006716
  3. Activity of eltrombopag in severe aplastic anemia.
    Scheinberg P. · · 2018 · cited 21× · PMID 30504345 · DOI 10.1182/asheducation-2018.1.450

Verify or expand the search:

Other trials of Eltrombopag

Trials testing the same drug.

Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials

Trials by the same sponsor.

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Data sources for this page

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