An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443

Biogen Idec Research Limited0 个研究点目标入组 292 人开始时间: 2016年5月23日最近更新: 2024年6月10日

试验速览

暂无简介。

•Subjects must meet all of the following criteria at Screening to be eligible:
•1. Signed informed consent of parent or guardian and signed informed assent of subject, if indicated per subject’s age and institutional guidelines.
•2. Completion of the index study in accordance with the study protocol or as a result of Sponsor decision (e.g., early termination of the index study) within the preceding 16 weeks.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 278
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Subjects meeting any of the following criteria are not eligible for the study:
•1. Have any condition or worsening condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
•2. Clinically significant abnormalities in hematology or clinical chemistry parameters or electrocardiogram (ECG), as assessed by the Site Investigator, at the Screening visit that would render the participant unsuitable for participation in the study
•3. Participant's parent or legal guardian is not willing or able to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study
•4. Treatment with another investigational agent, biological agent, or device within one month of Screening, or 5 half-lives of study agent, whichever is longer
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

发起方