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NCT01791101: ITP0511
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
Phase 2 trial testing Eltrombopag in Thrombocytopenia in 10 participants. Completed in 26 June 2020.
26 June 2020
Quick facts
| Lead sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 16 September 2013 |
| Primary completion | 26 June 2020 |
| Estimated completion | 26 June 2020 |
| Sites | 16 locations across Italy |
Drugs / interventions tested
- Eltrombopag (ELTROMBOPAG) — full drug profile →
Conditions studied
- Thrombocytopenia — all drugs for Thrombocytopenia →
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto — full company profile →
Who can join
18 and older, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if patients will achieve response after 2 months of therapy, they will continue eltrombopag for a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of 40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses will be observed, it will be concluded that eltrombopag is worth of further studies.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Rescue treatment with eltrombopag in refractory cytopenias after allogeneic stem cell transplantation.
Aydin S, Dellacasa C, Manetta S, Giaccone L, et al · · 2020 · cited 10× · PMID 33194161 · DOI 10.1177/2040620720961910 -
Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation.
Desborough M, Estcourt LJ, Doree C, Trivella M, et al · · 2016 · cited 10× · PMID 27548292 · DOI 10.1002/14651858.cd010982.pub2 -
Eltrombopag: Role in Cytopenias Following Hematopoietic Stem Cell Transplantation.
Vasudevan Nampoothiri R, Kumar R. · · 2020 · cited 7× · PMID 32425372 · DOI 10.1007/s12288-019-01194-7 -
Efficacy and Immunomodulating Properties of Eltrombopag in Aplastic Anemia following Autologous Stem Cell Transplant: Case Report and Review of the Literature.
Bortolotti M, Pettine L, Zaninoni A, Croci GA, et al · · 2022 · cited 6× · PMID 35455416 · DOI 10.3390/ph15040419
Verify or expand the search:
- PubMed search for NCT01791101
- 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 recruiting trials for Thrombocytopenia
Currently open trials in the same condition.
- NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
- NCT07442513 — Comparison of Etamsylate Versus Placebo to Prevent Bleeding in HSCT · Phase 3 · recruiting
- NCT07257809 — Herombopag Treated T-DM1 Induced Platelet Reduction · Phase 2 · recruiting
- NCT06676904 — Neonatal Platelet Transfusion Threshold Trial · NA · recruiting
- NCT06886516 — Apixaban in Thrombocytopenia · EARLY_PHASE1 · recruiting
Other Gruppo Italiano Malattie EMatologiche dell'Adulto trials
Trials by the same sponsor.
- NCT07356960 — Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world · not yet recruiting
- NCT07158294 — Identification of BCR::ABL1 Mutations by Digital PCR in CML · NA · not yet recruiting
- NCT07249606 — Momelotinib Effectiveness in Myelofibrosis · not yet recruiting
- NCT06880601 — Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma · Phase 2 · not yet recruiting
- NCT06657846 — HRQoL and Financial Toxicity in Patients With VEXAS Syndrome · 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 NCT01791101 (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 Gruppo Italiano Malattie EMatologiche dell'Adulto
- Last refreshed: 11 June 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/NCT01791101.
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