jRCT2031250505招募中不适用
Investigator-Initiated Phase II Clinical Trial of MA-5 for Mitochondrial Disease An Exploratory, Investigator-Initiated Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MA-5 in Patients with Mitochondrial Disease and Hearing Loss
未提供0 个研究点目标入组 15 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 16age old over 至 65age old under（—）
- 性别
- All
入选标准
- •1.Patients with mitochondrial disease who have hearing loss
- •2.Patients aged 16 years or older and 65 years or younger at the time of informed consent
- •3.Patients who have provided written informed consent of their own free will. However, if the patient is a minor, written informed consent must be obtained from a legally authorized representative of their own free will.
排除标准
- •1.Patients with large tympanic membrane perforation, active middle ear disease, or a history of major middle ear surgery
- •2.Patients with evidence of or diagnosed with traumatic brain injury or central hearing loss
- •3.Patients with hearing loss caused by radiation therapy to the head and neck or by administration of platinum-containing agents or aminoglycoside antibiotics
- •4.Patients with hearing loss due to causes other than mitochondrial disease
- •5.Patients using a cochlear implant
- •6.Patients with severe hearing impairment (average hearing level 90 dB or higher)
- •7.Patients who have newly started or changed the dosage of taurine, water-soluble vitamins, or coenzyme Q10 within 12 weeks prior to informed consent
- •8.Patients requiring mechanical ventilation
- •9.Patients with status epilepticus or severe coma
- •10.Patients with concomitant sepsis
- •11.Patients with renal impairment (estimated glomerular filtration rate eGFR less than 30 mL per minute per 1.73 square meters)
- •12.Patients with hepatic impairment (aspartate aminotransferase AST or alanine aminotransferase ALT greater than three times the institutional upper limit of normal)
- •13.Patients with cardiac dysfunction (left ventricular ejection fraction LVEF 35 percent or less)
- •14.Patients with a history of clinically significant systemic autoimmune disease such as rheumatoid arthritis, Sjogrens syndrome, multiple sclerosis, or psoriasis
- •15.Patients with cognitive impairment for whom cognitive testing MMSE is deemed infeasible by the investigator
- •16.Patients who have participated in another clinical trial or investigational study within 12 weeks prior to informed consent. Participation in non-interventional studies is acceptable if completed before consent
- •17.Patients who are pregnant or breastfeeding, who may be pregnant, or who intend to become pregnant, or whose partner intends to become pregnant
- •18.Patients unable to use effective contraception such as condoms, intrauterine devices, or oral contraceptives appropriately from the date of consent through the end of the follow-up period
- •19.Patients with a history of severe drug hypersensitivity
- •20.Any other patients deemed inappropriate by the investigator
研究者
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