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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 is a Phase 3 study that has completed, run by Rebiotix. The registered enrollment target is 793 participants.
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.
Interventions
- DRUG RBX2660
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2023-07-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03931941
The ClinicalTrials.gov registry entry for NCT03931941 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 793 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rebiotix, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RBX2660 is the first listed.
NCT03931941 reports 0 study locations.
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.
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