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NCT05153499 · ClinicalTrials.gov registry record · Phase 3
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
A Phase 3 study, sponsored by Finch Research and Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT05153499: Clinical Trial Phase 3 study, sponsored by Finch Research and Development.
NCT05153499 is a Phase 3 study that was terminated before completion, run by Finch Research and Development. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05153499, a Phase 3 study, was terminated before completion, sponsored by Finch Research and Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.
Primary Outcome
No data displayed because Outcome Measure has zero participants analyzed.
Interventions
- OTHER Placebo
- BIOLOGICAL CP101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2023-02-24 |
| Phase | Phase 3 |
Why NCT05153499 stopped before completion
NCT05153499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05153499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05153499 about?
NCT05153499 is a clinical study titled "A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)". This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-...
What is the current status of trial NCT05153499?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2021-11-15. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT05153499?
The interventions under investigation include: Placebo (OTHER), CP101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05153499?
This trial is sponsored by Finch Research and Development, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05153499's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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