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NCT03413306
Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA
Phase 3 trial testing Eltrombopag in Acquired Aplastic Anemia in 100 participants. Status unknown.
20 October 2022
Quick facts
| Lead sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 10 December 2016 |
| Primary completion | 20 October 2022 |
| Estimated completion | 20 October 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Eltrombopag (ELTROMBOPAG) — full drug profile →
- IST (ATG + CsA) — full drug profile →
Conditions studied
- Acquired Aplastic Anemia — all drugs for Acquired Aplastic Anemia →
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):
-
Activity of eltrombopag in severe aplastic anemia.
Scheinberg P. · · 2018 · cited 31× · PMID 30425070 · DOI 10.1182/bloodadvances.2018020248 -
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 -
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:
- PubMed search for NCT03413306
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eltrombopag
Trials testing the same drug.
- NCT07189910 — Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP · Phase 4 · not yet recruiting
- NCT07113743 — Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease · Phase 1, PHASE2 · enrolling by invitation
- NCT07093606 — Eltrombopag Induced Liver Dysfunction During Treatment of Immunethrombocytopenic Purpura · NA · recruiting
- NCT06345495 — High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly · Phase 2 · recruiting
- NCT05653219 — A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia · Phase 3 · active not recruiting
Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials
Trials by the same sponsor.
- NCT07316595 — Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome · Phase 2 · not yet recruiting
- NCT07375563 — Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Ris · Phase 3 · recruiting
- NCT07366801 — Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus H · Phase 2, PHASE3 · recruiting
- NCT07232134 — The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia · Phase 3 · recruiting
- NCT06587191 — Emapalumab Efficacy in Children With Primary Hemophagocytic Lymphohistiocytosis · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03413306 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Last refreshed: 15 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03413306.
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