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Clinical Trial Summary

Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02840110
Study type Observational
Source Cogent Biosciences, Inc.
Contact
Status Terminated
Phase
Start date October 2016
Completion date February 23, 2021

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