An Open-label Extension Study for Patients with Spinal Muscular Atrophy who Previously Participated in Investigational Studies of ISIS 396443

Ionis Pharmaceuticals, Inc.0 个研究点目标入组 274 人开始时间: 2016年2月3日最近更新: 2016年5月2日

试验速览

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•Subjects must meet all of the following criteria at Screening to be eligible:
•1.Signed informed consent of parent or guardian. 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 within preceding 12 weeks
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 274
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•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 new condition or worsening of existing condition which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study
•2.Clinically significant abnormalities in hematology or clinical chemistry parameters or ECG, as assessed by the Site Investigator, at the Screening visit that would render the subject unsuitable for participation in the study
•3.Subject?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

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