JPRN-C000000327已完成3 期
Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections (Multicenter double-blind randomized parallel group comparative study with heparin sodium as control drug) - Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infections
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(i)Patients showing lethal or life-threatening hemorrhage (intracranial, gastrointestinal or pulmonary hemorrhage, and others). (ii)Patients having a strong possibility of onset of lethal or life-threatening hemorrhage. (iii)Patients with a history (within the past one year) of cerebrovascular disorders (cerebral hemorrhage, cerebral infarction, and others). (iv)Patients who recently underwent surgery of the central nervous system or were subjected to trauma. (v)Children under 15. (vi)Patients with a history of hypersensitivity to protein preparations or unfractionated heparin preparations. (vii)Pregnant women, nursing mothers or possibly pregnant women. (viii)Patients whose skin test for ART-123 is positive. (ix)Patients undergoing treatment by dialysis or with drug excretion severely damaged by serious renal disorder. (x)Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others. (xi)Patients believed to die early even if they recovered from DIC, making it difficult to ensure a sufficient period of administration of the study drug and to obtain data on the efficacy and safety. (xii)Patients given a study drug within last 6 months. (xiii)Patients participating in the past trial of ART-123. (xiv)Patients receiving preadministration of unfractionated heparin for DIC (within 3 months before the start of administration of study drug). (xv)Other patients judged to be inappropriate at the discretion of investigators (or assistant investigators).
研究者
相似试验
未知
3 期
Phase III Clinical Study on ART-123 in patients with disseminated intravascular coagulation (DIC) directly caused by malignant hematopoietic tumors or infectionsDisseminated intravascular coagulation (DIC)JPRN-jRCT2080220059ASAHIKASEI PHARMA CORPORATIO
已完成
3 期
Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosisAcute exacerbation of idiopathic pulmonary fibrosis (AE-IPF)JPRN-jRCT2080223271ASAHI KASEI PHARMA CORPORATIO74
未知
4 期
A postmarketing clinical study on ART-123 in patients with DIC caused by solid tumorDisseminated intravascular coagulation (DIC) directly caused by solid tumorJPRN-jRCT1080220847ASAHI KASEI PHARMA CORPORATIO100
暂停
1 期
TAS0313 Phase I/II studySolid tumor (urothelial carcinoma, and so on)JPRN-jRCT2080223768Taiho Pharmaceutical Co., Ltd.130
未知
3 期
Phase 3 clinical study of AK-120 in patients with herpes zosterHerpes zosterJPRN-jRCT2080220058ASAHIKASEI PHARMA CORPORATIO