Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia
NCT ID: NCT04289207
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
55 participants
INTERVENTIONAL
2020-03-01
2021-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Romiplostim and danazol
Treatment group (romiplostim and danazol)
Romiplostim and danazol
Treatment with romiplostim and danazol
Interventions
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Romiplostim and danazol
Treatment with romiplostim and danazol
Eligibility Criteria
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Inclusion Criteria
* diagnosed with immune thrombocytopenia (bone marrow examination is not necessary)
* failed to achieve platelet count over 50X10\^9/L with eltrombopag
* ECOG performance status 0,1,2
* available to obtain informed consent
Exclusion Criteria
* HIV positive patients
* diagnosed with systemic lupus erythematosus or other autoimmune disorders
* unable to intake orally or absorb through gastrointestinal tract
* pregnant or breast-feeding
* diagnosed with uncontrolled seizure or other neuropsychiatric disorders
* diagnosed with clinically significant cardiovascular events within 6 months or dyspnea on exertion evaluated to New York Heart Association Functional Classification III or IV
* diagnosed with clinically significant cerebrovascular disorders
* previously diagnosed or treated with thromboembolism
* current treating malignant diseases
* currently accompanied by uncontrolled infection or active bleeding
* with blood test results as follows; total bilirubin \> 2xUNL(upper normal limit), AST/ALT \> 1.5xUNL, creatinine \> 1.5xUNL, glomerular filtration rate \< 30ml/min/1.73m\^2
* registered to other clinical trials for treatment of immune thrombocytopenia
* judged to be inappropriate for clinical trial by doctor in charge
18 Years
ALL
No
Sponsors
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Kyowa Kirin Korea Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Youngil Koh
Associate professor
Principal Investigators
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Youngil Koh
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Central Contacts
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References
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Cooper N, Bussel J. The pathogenesis of immune thrombocytopaenic purpura. Br J Haematol. 2006 May;133(4):364-74. doi: 10.1111/j.1365-2141.2006.06024.x.
Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009 Mar 5;113(10):2161-71. doi: 10.1182/blood-2008-04-150078. Epub 2008 Nov 3.
Wong RSM, Saleh MN, Khelif A, Salama A, Portella MSO, Burgess P, Bussel JB. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017 Dec 7;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707. Epub 2017 Oct 17.
Khellaf M, Viallard JF, Hamidou M, Cheze S, Roudot-Thoraval F, Lefrere F, Fain O, Audia S, Abgrall JF, Michot JM, Dauriac C, Lefort S, Gyan E, Niault M, Durand JM, Languille L, Boutboul D, Bierling P, Michel M, Godeau B. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013 Jun;98(6):881-7. doi: 10.3324/haematol.2012.074633. Epub 2013 Feb 26.
Other Identifiers
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0620200130
Identifier Type: -
Identifier Source: org_study_id