NCT07301450Temporarily Not Available不适用
An Expanded Access Program of Garetosmab in Patients With Fibrodysplasia Ossificans Progressiva
试验速览
- 阶段
- 不适用
- 状态
- Temporarily Not Available
研究概览
简要总结
The objective of this Expanded Access Program (EAP) is to provide garetosmab to patients with Fibrodysplasia Ossificans Progressiva (FOP) who have completed the double-blind treatment period of the parent study, OPTIMA (R2477-FOP-2175 [NCT05394116]), prior to marketing authorization approval, unless otherwise specified by country specific regulations for rare diseases.
详细描述
The program will enroll approximately up to 55 patients, globally.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with FOP who must have completed the double-blind treatment period of the parent study OPTIMA (R2477-FOP-2175 [NCT05394116]), as defined in the protocol
- •If the patient has progression of disease with Cumulative Analogue Joint Involvement Scale (CAJIS) >19 at the time of EAP enrollment, the case will require discussion and evaluation between the treating physician and EAP Medical Director to determine final eligibility
排除标准
- •1. Patients participating in OPTIMA who are considered by the treating physician as inappropriate for this program for any reason
- •NOTE: Other protocol defined inclusion / exclusion criteria apply
研究者
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