Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Finch Research and Development. The registered enrollment target is 19 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05153499
The ClinicalTrials.gov registry entry for NCT05153499 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Finch Research and Development, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05153499 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.