Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)
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|ClinicalTrials.gov Identifier: NCT02437500|
Expanded Access Status : Available
First Posted : May 7, 2015
Last Update Posted : February 8, 2023
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|First Submitted Date||May 5, 2015|
|First Posted Date||May 7, 2015|
|Last Update Posted Date||February 8, 2023|
|Brief Title||Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)|
|Brief 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.|
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 Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Other Name: Eubacterial Spores, Purified Suspension, Encapsulated
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||Not Provided|
|Removed Location Countries||United States|
|Current Responsible Party||Seres Therapeutics, Inc.|
|Original Responsible Party||Same as current|
|Current Study Sponsor||Seres Therapeutics, Inc.|
|Original Study Sponsor||Same as current|
|PRS Account||Seres Therapeutics, Inc.|
|Verification Date||February 2023|