Overview

Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection

Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label study for patients who have a recurrence of Clostridium difficile infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004 study has completed enrollment, SERES-005 was amended to allow expanded access in accordance with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for the SERES-004 study.
Details
Lead Sponsor:
Seres Therapeutics, Inc.
Collaborators:
INC Research
Syneos Health