A long-term study of RBM-007 in children with achondroplasia

onaka Yosuke0 个研究点目标入组 12 人开始时间: 2022年9月16日最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•(1) Has completed the early phase II study, has completed the safety and efficacy evaluation (height growth velocity, etc.) by Investigator, and has been judged to have no safety issues
•(2) Able to obtain written informed consent from surrogate decision maker (parents, relatives or legal representative) before study entry
•Able to obtain written informed assent from the patient after explaining the contents of this study in the assent document (if possible)
•(3) Able to perform all the tests and administration of investigational product described in the protocol, judged by Investigator

•(1) Inadequate as a patient for this study based on examinations, observations, etc. at the end of the early phase II study
•(2) Highly likely to be unable to complete this study due to poor compliance treated with RBM-007 or poor implementation of regular examinations and observation items, judged by the Investigator
•(3) Diagnosed with a closed growth plate in the examination at the end of the early phase II study
•(4) Has a positive pregnancy test at the end of the early phase II study (only female patients)
•(5) Inadequate as a patient for this study for any other reason than above, considered by the Investigator

发起方

onaka Yosuke