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Clinical Trial Summary

This is an open-label extension of CDI-001 (subsequently referred to as PRISM 3), and is evaluating the safety and efficacy in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101.

Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03497806
Study type Interventional
Source Finch Research and Development LLC.
Contact
Status Enrolling by invitation
Phase Phase 2
Start date May 1, 2018
Completion date May 1, 2020

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