2023-507633-21-00撤回3 期
An Open-Label, Multicenter Extension Study Providing Continued Access to Treatment in Patients with a Neurological Disease Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and without Access to A Post Trial Access Program
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 196
- 试验地点
- 24
- 主要终点
- Not available
研究概览
简要总结
To provide continued treatment with Roche IMP(s)-based therapy for eligible patients with a neurological disease still on study treatment at the time of roll-over from the parent study who do not have reasonable access to the study treatment locally.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- An Open-label, Multicenter Extension Study In Patients With Neurological Disease Previously Enrolled
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed extension study Informed Consent Form
- •Eligible for continuing on Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol
- •First dose of study treatment in this extension study will be received within the treatment window allowed by the parent study.
- •Continue to benefit from the Roche active substance at the time of roll-over from the parent study as assessed by the investigator
- •Ability to comply with the extension study protocol, per investigator’s judgement
- •Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
排除标准
- •Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- •Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient
- •Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient
- •Treatment with any other neurological treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- •Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- •Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Not available
Not available
次要结局
- N/A
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (24)
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