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

Kyowa Kirin Co., Ltd0 个研究点目标入组 52 人开始时间: 2018年1月23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: 52

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: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1. Voluntary written informed consent to participate in the study
•2. Diagnosis as HAM according to the second edition of HAM Treatment Manual
•3. At least 1-year history of HAM
•4. Ongoing medication 1) for HAM, with no changes in 3 months before enrollment; or inadequate response or intolerance to prior medication, 2) which must have been discontinued for at least 3 months before enrollment. Subjects on maintenance therapy with steroids must have been receiving =< 10 mg/day prednisolone equivalent continuously for at least 3 months before enrollment.
•1) Steroids, salazosulfapyridine, or >= 1.5 g/day vitamin C
•2) Steroids, IFN-Alpha, salazosulfapyridine, or >= 1.5 g/day vitamin C
•5. No change in the degree of motor dysfunction for at least 3 months before the date of screening, as judged by the investigator or subinvestigator
•6. A OMDS of >=3 at screening and able to walk >= 10 m at screening (use of a single cane or double canes is allowed)

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

相似试验

已完成

3 期

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)HTLV-1 Associated Myelopathy (HAM)

JPRN-UMIN000029913Kyowa Kirin Co., Ltd.67

已完成

3 期

A Phase 3 Study of KW-0761 in Subjects with HTLV-1 Associated Myelopathy (HAM)HTLV-1 associated Myelopathy (HAM)

JPRN-jRCT2080223553Kyowa Kirin Co., Ltd.52

进行中（未招募）

1 期

Study investigating a new medicine - Doravirine in patients diagnosed with HIV-1 without previous treatment for this disease. Neither the doctor or patient will know the treatment group. All the patients will be treated with Truvada or Epzicom/Kivexa, some of the patients will be treated in addition with Doravirine, while the others will be treated in addition with Darunavir plus Ritonavir.Human immunodeficiency virus type 1 (HIV-1) infection in HIV-infected patients not treated previously.MedDRA version: 18.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862

EUCTR2014-001127-69-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.680

进行中（未招募）

1 期

EUCTR2014-001127-69-DKMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.680

进行中（未招募）

1 期

EUCTR2014-001127-69-ROMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.680