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Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)

Clostridioides Difficile Infection Clinical Trial

Official title:
Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)

Clinical Trial Summary

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI) and to monitor subject safety and report to regulatory authorities, as appropriate.

Clinical Trial Description

SERES-016 is a multicenter, expanded-access program (EAP) of SER-109 for subjects with RCDI conducted in the US. Up to approximately 90 subjects are expected to be treated with SER-109, or until SER-109 investigational product is exhausted. Within 3 days after end of antibiotics and on the day preceding SER-109, a bowel cleanse should be administered. Subjects who meet all the inclusion criteria and none of the exclusion criteria are eligible for participation in the EAP. Each subject (or subject's legally authorized representative) will have to sign an informed consent form (ICF) indicating their consent to participate in the EAP. Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02437500
Study type Expanded Access
Source Seres Therapeutics, Inc.
Contact
Status Approved for marketing
Phase
View Details
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