JPRN-jRCTs031190141招募中1 期
Prospective, single-center, cross-over trial to verify safety and effectiveness of nicotinamide riboside for patients with Werner syndrome - EMPOWER
Yokote Koutaro0 个研究点目标入组 30 人开始时间: 2019年11月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- •Patients who meet all of the following criteria are included.
- •1) Patients who are diagnosed with Werner syndrome
- •2) Patients who explained the study contents using explanatory documents and obtained written consent for study participation from the person or the representative
- •3) Male or female 20 years old and more
- •4) Patients whose hematocrit value is judged to be clinically acceptable by the investigator or co-investigator
- •5) Patients who can comply with the protocol requirements by the investigator or co-investigator
排除标准
- •Patients who meet any of the following criteria are not included.
- •1) Disease or (including laboratory values) that may be influenced by the interpretation of data or safety, or the protocol evaluation cannot be performed safely, as the investigator or co-author decides Patients with clinically significant abnormalities.
- •2) Patients who have significant dehydration as judged by the principal investigator or co-investigator
- •3) Patients with pericardial fluid, ascites and pleural effusion
- •4) Patients participating in another clinical trial within 30 days before obtaining consent
- •5) Clinical signs seen at initial screening are the final stage of Werner syndrome progression, and safe completion of the study and patients judged to be difficult to assess, including:
- •- Patients who received continuous or intermittent home oxygen therapy for 6 months before obtaining consent
- •- Patients who received at least 2 hospitalizations for pneumonia during the 12 months prior to obtaining consent
- •- Patients who show at least 10% net weight loss and do not recover as stated on the chart. This includes significant net weight loss over the last six months (beyond the estimated measurement error).
- •- Patients requiring CKD stage 5 and/or peritoneal or hemodialysis
- •- Patients whose liver function test value is more than 3 times the upper limit of normal
- •6) Patients with a history of hypersensitivity to nicotinamide riboside
- •7) Patients with a history of serious drug hypersensitivity or allergic reaction such as anaphylaxis
- •8) Patients whose estimated survival time is judged to be at terminal stage less than 2 years
- •9) Patients who cannot comply with study requirements and procedures
- •10) Patients with malignancy or patients with a history of malignancy
- •11) Patients suspected of having cancer on chest X-ray
- •12) Patients who are positive for tumor marker test (CEA, CA19-9) (if positive, upper and lower gastrointestinal endoscopy must show negative for cancer, for enrollment)
- •13) Pregnant, brestfeeding, possibly pregnant or planned patients
- •14) Patients who are considered inappropriate by the investigator or co-investigators
- •15) Patients taking nicotinamide riboside within 30 days of screening visit
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