2024-512584-31-00招募中3 期
An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-hOTOF Gene Therapy in Individuals with Sensorineural Hearing Loss due to Otoferlin Gene (OTOF) Mutations
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Akouos Inc.
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety: Incidence and frequency of AEs
研究概览
简要总结
To evaluate the long term safety of AAVAnc80-hOTOF, including late-occurring adverse events.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Long Term Follow-Up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Individuals with OTOF-mediated hearing loss who received an intracochlear administration of AAVAnc80- hOTOF in the AK-OTOF-101 clinical trial (either Part A or Part B).
- •Legally authorized representative and/or participant willingness to comply with all study requirements, as evidenced by successful completion of the informed consent process or permission and participant assent process (where appropriate).
排除标准
- •Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study. Potential participants will not be excluded based on their sex, gender, race, or ethnicity.
结局指标
主要结局
Safety: Incidence and frequency of AEs
Safety: Incidence and frequency of AEs
Safety: Concomitant Medications
Safety: Concomitant Medications
Safety: Clinical labs: chemistries, hematology (CBC with differential), urinalysis
Safety: Clinical labs: chemistries, hematology (CBC with differential), urinalysis
Safety: Physical examination and vital signs
Safety: Physical examination and vital signs
Safety: Otoscopic examination
Safety: Otoscopic examination
Safety: Vestibular screening
Safety: Vestibular screening
Safety: Tympanometry
Safety: Tympanometry
次要结局
- Efficacy: Diagnostic ABR testing threshold
- Efficacy: Age-appropriate behavioral audiometry
- Efficacy: Standard word or speech recognition testing
- Efficacy: Standard auditory questionnaires
研究者
Akouos Clinical Trials
Scientific
Akouos Inc.
研究点 (1)
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