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NCT03183141 · ClinicalTrials.gov registry record · Phase 3
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
A Phase 3 study, sponsored by Seres Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 263
- Enrollment target
NCT03183141 is a Phase 3 study that has completed, run by Seres Therapeutics. The registered enrollment target is 263 participants.
The verdict
NCT03183141, a Phase 3 study, has completed, sponsored by Seres Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 263 participants
- Enrollment target
Study Summary
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.
Interventions
- BIOLOGICAL SER-109
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2022-04-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03183141
The ClinicalTrials.gov registry entry for NCT03183141 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seres Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SER-109 is the first listed.
NCT03183141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03183141 about?
NCT03183141 is a clinical study titled "ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection". Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within...
What is the current status of trial NCT03183141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 263 participants. The study started on 2017-10-23. Estimated completion is 2022-04-29.
What interventions are being tested in trial NCT03183141?
The interventions under investigation include: SER-109 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03183141?
This trial is sponsored by Seres Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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