Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- EG 427
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Incidence of treatment emergent serious adverse events (TESAEs)
研究概览
简要总结
The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.
详细描述
The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics.
This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.
排除标准
- •Participant plans to participate in another investigational gene therapy study
- •Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator
研究组 & 干预措施
Patients who received EG110A in a clinical study, regardless of dose
干预措施: Urodynamics (Other)
Patients who received EG110A in a clinical study, regardless of dose
干预措施: EG110A (Drug)
Patients who received EG110A in a clinical study, regardless of dose
干预措施: Patient-reported Outcome (Other)
结局指标
主要结局
Incidence of treatment emergent serious adverse events (TESAEs)
时间窗: 5 years
Any participant who has a reported treatment emergent serious adverse event (TESAE)
Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)
时间窗: 5 years
Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)
次要结局
- Patient-reported outcome (PRO) questionnaire(5 years)
- Duration of response to EG110A(5 years)