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NCT03931941 · ClinicalTrials.gov registry record · Phase 3
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
A Phase 3 study, sponsored by Rebiotix.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT03931941: Completed Phase 3 study, sponsored by Rebiotix.
NCT03931941 is a Phase 3 study that has completed, run by Rebiotix. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931941, a Phase 3 study, has completed, sponsored by Rebiotix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
Primary Outcome
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
Interventions
- DRUG RBX2660
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2023-07-21 |
| Phase | Phase 3 |
What the finished NCT03931941 record still lists
NCT03931941 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which RBX2660 is the first listed.
NCT03931941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03931941 about?
NCT03931941 is a clinical study titled "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)". This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two epis...
What is the current status of trial NCT03931941?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2019-07-30. Estimated completion is 2023-07-21.
What interventions are being tested in trial NCT03931941?
The interventions under investigation include: RBX2660 (DRUG).
Who is sponsoring clinical trial NCT03931941?
This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03931941's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 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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