A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia
NCT ID: NCT02094417
Last Updated: 2024-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2014-04-14
2017-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AMG531 (Dose 1)
AMG531
Subcutaneous, weekly injection
AMG531 (Dose 2)
AMG531
Subcutaneous, weekly injection
AMG531 (Dose 3)
AMG531
Subcutaneous, weekly injection
AMG531 (Dose 4)
AMG531
Subcutaneous, weekly injection
Interventions
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AMG531
Subcutaneous, weekly injection
Eligibility Criteria
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Inclusion Criteria
* Platelet ≤ 30,000/μL
Exclusion Criteria
* HIV positivity
* Bone marrow reticulin grade of \> 1
* Clinically significant cardiac disease
* Arterial or venous thrombosis within the last 1 year before enrollment
* Other cause of thrombocytopenia
* AA with hemolytic predominant paroxysmal nocturnal hemoglobinuria (PNH)
* Uncontrolled diabetes
* Receiving any agent used to treat AA, including antithymocyte globulin (ATG) or ATG + cyclosporine within 6 months before starting study treatment and/or cyclosporine or anabolic hormone within 6 weeks before starting the study treatment
* History of PEG-rHuMGDF, recombinant human thrombopoietin, AMG531, and other thrombopoietin (TPO)-receptor agonist
* Who plans to conduct hematopoietic stem cell transplantation within 1 year
19 Years
ALL
No
Sponsors
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Kyowa Kirin Korea Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Korea, Republic of
Seoul, , South Korea
Countries
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References
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Jang JH, Mitani K, Tomiyama Y, Miyazaki K, Nagafuji K, Usuki K, Uoshima N, Fujisaki T, Kosugi H, Matsumura I, Sasaki K, Kizaki M, Sawa M, Hidaka M, Kobayashi N, Ichikawa S, Yonemura Y, Murotani K, Shimizu M, Matsuda A, Ozawa K, Nakao S, Lee JW. Predictive factors of romiplostim response in patients with refractory aplastic anemia: data from two clinical trials. Ann Hematol. 2025 Aug;104(8):4003-4011. doi: 10.1007/s00277-025-06337-7. Epub 2025 Jul 1.
Lee JW, Lee SE, Jung CW, Park S, Keta H, Park SK, Kim JA, Oh IH, Jang JH. Romiplostim in patients with refractory aplastic anaemia previously treated with immunosuppressive therapy: a dose-finding and long-term treatment phase 2 trial. Lancet Haematol. 2019 Nov;6(11):e562-e572. doi: 10.1016/S2352-3026(19)30153-X. Epub 2019 Aug 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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531-KR001
Identifier Type: -
Identifier Source: org_study_id
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