A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
NCT ID: NCT04214951
Last Updated: 2020-10-20
Study Results
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View full resultsBasic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Recombinant human thrombopoietin (rh-TPO) group
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO)
Patients will be given rh-TPO 300 U/kg once daily for 21 days.
Eltrombopag group
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag
Patients will be given eltrombopag 50mg once daily for 6 weeks.
Interventions
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Eltrombopag
Patients will be given eltrombopag 50mg once daily for 6 weeks.
Recombinant human thrombopoietin (rh-TPO)
Patients will be given rh-TPO 300 U/kg once daily for 21 days.
Eligibility Criteria
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Inclusion Criteria
2.Primary ITP
3.Platelet count ≤ 30 × 109/l
4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values
5.Available follow-up of 2 months at least for each period
6.Failed initial glucocorticosteroid treatment
7.Unwillingness to accept splenectomy or failed splenectomy
\-
Exclusion Criteria
2. Malignancy
3. Congenital or acquired immunologic deficit
4. History of thrombosis plus two or more risk factors
5. Nursing or pregnant women
6. Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl
7. Severe heart and lung dysfunctions -
18 Years
75 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiao Hui Zhang
Clinical Professor
Principal Investigators
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Xiao Hui Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University Institute of Hematology
Beijing, Beijing Municipality, China
Countries
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References
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Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16.
Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.
Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012 Aug 2;120(5):960-9. doi: 10.1182/blood-2011-12-309153. Epub 2012 Jun 26.
Deutsch VR, Tomer A. Advances in megakaryocytopoiesis and thrombopoiesis: from bench to bedside. Br J Haematol. 2013 Jun;161(6):778-93. doi: 10.1111/bjh.12328. Epub 2013 Apr 18.
Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013 Jul;98(1):10-23. doi: 10.1007/s12185-013-1382-0. Epub 2013 Jul 3.
Bussel JB, Lakkaraja M. Thrombopoietic agents: there is still much to learn. Presse Med. 2014 Apr;43(4 Pt 2):e69-78. doi: 10.1016/j.lpm.2014.02.008. Epub 2014 Mar 27.
Wormann B. Clinical indications for thrombopoietin and thrombopoietin-receptor agonists. Transfus Med Hemother. 2013 Oct;40(5):319-25. doi: 10.1159/000355006. Epub 2013 Sep 11.
Wang S, Yang R, Zou P, Hou M, Wu D, Shen Z, Lu X, Li Y, Chen X, Niu T, Sun H, Yu L, Wang Z, Zhang Y, Chang N, Zhang G, Zhao Y. A multicenter randomized controlled trial of recombinant human thrombopoietin treatment in patients with primary immune thrombocytopenia. Int J Hematol. 2012 Aug;96(2):222-8. doi: 10.1007/s12185-012-1124-8. Epub 2012 Jun 30.
Erickson-Miller CL, Delorme E, Tian SS, Hopson CB, Landis AJ, Valoret EI, Sellers TS, Rosen J, Miller SG, Luengo JI, Duffy KJ, Jenkins JM. Preclinical activity of eltrombopag (SB-497115), an oral, nonpeptide thrombopoietin receptor agonist. Stem Cells. 2009 Feb;27(2):424-30. doi: 10.1634/stemcells.2008-0366.
Erhardt JA, Erickson-Miller CL, Aivado M, Abboud M, Pillarisetti K, Toomey JR. Comparative analyses of the small molecule thrombopoietin receptor agonist eltrombopag and thrombopoietin on in vitro platelet function. Exp Hematol. 2009 Sep;37(9):1030-7. doi: 10.1016/j.exphem.2009.06.011. Epub 2009 Jul 24.
Gonzalez-Porras JR, Godeau B, Carpenedo M. Switching thrombopoietin receptor agonist treatments in patients with primary immune thrombocytopenia. Ther Adv Hematol. 2019 May 9;10:2040620719837906. doi: 10.1177/2040620719837906. eCollection 2019.
Cantoni S, Carpenedo M, Mazzucconi MG, De Stefano V, Carrai V, Ruggeri M, Specchia G, Vianelli N, Pane F, Consoli U, Artoni A, Zaja F, D'adda M, Visentin A, Ferrara F, Barcellini W, Caramazza D, Baldacci E, Rossi E, Ricco A, Ciminello A, Rodeghiero F, Nichelatti M, Cairoli R. Alternate use of thrombopoietin receptor agonists in adult primary immune thrombocytopenia patients: A retrospective collaborative survey from Italian hematology centers. Am J Hematol. 2018 Jan;93(1):58-64. doi: 10.1002/ajh.24935. Epub 2017 Nov 9.
Cai X, Fu H, Zhao X, Lu J, Jiang Q, Chang Y, Huang X, Zhang X. Switching between eltrombopag and recombinant human thrombopoietin in patients with immune thrombocytopenia: an observational study. Chin Med J (Engl). 2022 Oct 5;135(19):2344-2350. doi: 10.1097/CM9.0000000000002346.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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ZXH-ITP2019
Identifier Type: -
Identifier Source: org_study_id
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