2023-11-01 - 2031-12-31
Phase III
召募中5
ICD-10C88.8
其他惡性免疫細胞增生性疾病
ICD-10C94.40
急性泛骨髓增生伴有骨髓纖維化，未達到緩解
ICD-10C94.41
急性泛骨髓增生伴有骨髓纖維化，緩解期
ICD-10C94.42
急性泛骨髓增生伴有骨髓纖維化，復發
ICD-10C94.6
骨髓生成不良疾病，未分類
ICD-10D46.9
骨髓分化不良症候群
ICD-10D46.A
骨髓分化不良症候群-頑固性血球減少伴有多系分化不良
ICD-10D46.B
骨髓分化不良症候群-頑固性血球減少伴有多系分化不良及環形鐵芽母細胞
ICD-10D46.C
骨髓分化不良症候群-單一del(5q)染色體異常
ICD-10D46.Z
其他骨髓分化不良症候群
ICD-10D47.1
慢性骨髓增生性疾病
ICD-10D47.3
本態性（出血性）血小板增多症
ICD-10D47.9
淋巴，造血及相關組織性態不明之腫瘤
ICD-10D47.Z1
移植器官後伴有淋巴組織增生性疾患(PTLD)
ICD-10D47.Z9
其他特定淋巴，造血及相關組織性態不明之腫瘤
ICD-9238.7
其他淋巴及造血組織之性態未明之腫瘤
一項第3期、隨機分配、開放性、活性藥物對照之臨床試驗，針對罹患原發性血小板增多症且對羥基尿素反應不足或不耐受的受試者，評估Bomedemstat（MK-3543／IMG-7289）相較於最佳現有療法（BAT）的安全性與療效。
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試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
試驗目的
藥品名稱
主成份
劑型
劑量
評估指標
主要納入條件
Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms
Has a bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance: hydroxyurea resistance (or inadequate response) or hydroxyurea Intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
Has a platelet count > 450 × 109/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 109/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior lines of therapy including hydroxyurea
主要排除條件
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
試驗計畫預計收納受試者人數
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台灣人數
15 人
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全球人數
340 人
