A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
研究概览
简要总结
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.
详细描述
Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral sensorineural hearing loss with an active decline in hearing in one ear
- •No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
- •Enrollment within 14 days of completion of corticosteroid therapy
- •Age 13 years and older
- •No evidence of neutropenia (low white blood cell count)
- •No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
- •May have concurrent, systemic autoimmune disease
排除标准
- •Age over 75, or less than 13
- •Neutropenia
- •Renal insufficiency
- •Pregnant females
- •Unilateral hearing loss
- •Patients with any immunodeficiency syndrome
- •Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
- •Patients with chronic infections
- •Patients treated for a malignancy within the past 3 years
- •Patients with a latex allergy
- •Patients with an inner ear anomaly
- •Patients with retrocochlear pathology
研究组 & 干预措施
Single Arm-Open Label
Single Arm-Open Label use of Anakinra
干预措施: Anakinra (Drug)
结局指标
主要结局
To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
时间窗: 180 days
The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.
次要结局
- Number of Serious Adverse Events Reported(84 days)
研究者
Andrea Vambutas
Professor of Otolaryngology & Molecular Medicine
Northwell Health