A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM) - A Phase 3 Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)

Kyowa Kirin Co., Ltd.0 个研究点目标入组 67 人开始时间: 2017年11月13日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Kyowa Kirin Co., Ltd.
入组人数: 67

研究概览入排标准研究者记录与标识符相似试验

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: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Any of the following significant concomitant diseases: Type 1 diabetes mellitus, Poorly controlled type 2 diabetes mellitus (HbA1c (NGSP) > 8.5%), Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification), Myocardial infarction within 1 year before enrollment, Unstable angina within 1 year before enrollment, Poorly controlled hypertension (systolic blood pressure > 150 mm Hg and diastolic blood pressure > 90 mm Hg at screening), Sever chronic lung disease requiring oxygen therapy, Multiple sclerosis or any other demyelinating disease, Epilepsy requiring treatment with antiepileptics (with the exception of epilepsy controlled by antiepileptics, with no occurrence of seizures for at least 3 years before informed consent), and Active malignancy (including ATL); or onset of malignancy or previous treatment for malignancy (with the exception of resected or surgically cured intraepithelial carcinoma of the uterine cervix, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or ductal breast carcinoma) within 5 years before informed consent 2) Active infection 3) Concurrent spinal cord compression lesion (e.g., cervical spine diseases, disk herniation, or ossification of the ligamentum flavum) , with the exception of conditions that would not affect efficacy evaluation in the study, as judged by the investigator or subinvestigator 4) Concurrent dementia 5) Concurrent psychiatric disorder, with the exception of conditions that would not affect obtaining informed consent or efficacy evaluation in the study, as judged by the investigator or subinvestigator 6) History of or current alcohol or drug dependence 7) Planned surgery during the study period 8) Any other conditions unsuitable for participation in the study in the opinion of the investigator or subinvestigator

研究者

发起方

Kyowa Kirin Co., Ltd.

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