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NCT03497806 · ClinicalTrials.gov registry record · Phase 2
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
A Phase 2 study of Clostridium Difficile Infection and CDI, sponsored by Finch Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT03497806: Completed Phase 2 study of Clostridium Difficile Infection and CDI, sponsored by Finch Research and Development.
NCT03497806 is a Phase 2 study of Clostridium Difficile Infection and CDI that has completed, run by Finch Research and Development. The registered enrollment target is 132 participants, below the 12,056-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497806, a Phase 2 study of Clostridium Difficile Infection and CDI, has completed, sponsored by Finch Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
Primary Outcome
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Conditions Studied
Interventions
- BIOLOGICAL CP101
Study Locations (20)
California
- Los Angeles - Los Angeles
- Murrieta - Murrieta
- Oakland - Oakland
- San Diego - San Diego
- San Francisco - San Francisco
Florida
- Jacksonville - Jacksonville
- Naples - Naples
- Pinellas Park - Pinellas Park
- Tampa - Tampa
Illinois
- Burr Ridge - Burr Ridge
- Chicago - Chicago
- Evanston - Evanston
- Maywood - Maywood
Connecticut
- Bridgeport - Bridgeport
- Hamden - Hamden
Arizona
- Scottsdale - Scottsdale
Colorado
- Aurora - Aurora
District of Columbia
- Washington DC - Washington D.C.
Georgia
- Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
What the finished NCT03497806 record still lists
NCT03497806 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 12,056-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 1 intervention - of which CP101 is the first listed.
NCT03497806 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03497806 about?
NCT03497806 is a clinical study titled "Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection". This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing...
What is the current status of trial NCT03497806?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2018-05-01. Estimated completion is 2021-04-01.
What conditions does trial NCT03497806 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection, CDI, Recurrent Clostridium Difficile Infection, C. Difficile, C. Diff.
What interventions are being tested in trial NCT03497806?
The interventions under investigation include: CP101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03497806?
This trial is sponsored by Finch Research and Development, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03497806 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03497806's enrollment target sits among peer trials
132 9th of 13 higher than 5 of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection 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.
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