Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
PRISM-EXT
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
1 other identifier
interventional
132
2 countries
57
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Typical duration for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
August 30, 2022
CompletedAugust 30, 2022
August 1, 2022
2.7 years
April 6, 2018
June 29, 2022
August 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
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.
Up to Week 8
Occurence of Treatment Emergent Adverse Events (TEAEs)
Week 8
Secondary Outcomes (1)
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Up to Week 24
Study Arms (1)
High Dose CP101
EXPERIMENTALThe active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program.
Interventions
Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
Eligibility Criteria
You may not qualify if:
- Pregnant, breast-feeding, or considering becoming pregnant during the study
- Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
- Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
- Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
- Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
- Major intra-abdominal surgery within the past 60 days prior to Screening
- Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
- History of total colectomy/ileostomy or bariatric surgery
- Planned hospitalization or invasive surgery during the study
- Severe acute illness unrelated to CDI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finch Research and Development LLC.lead
- Medpace, Inc.collaborator
Study Sites (57)
Scottsdale
Scottsdale, Arizona, 85054, United States
Los Angeles
Los Angeles, California, 90095, United States
Murrieta
Murrieta, California, 92563, United States
Oakland
Oakland, California, 94705, United States
San Diego
San Diego, California, 92123, United States
San Francisco
San Francisco, California, 94115, United States
Aurora
Aurora, Colorado, 80045, United States
Bridgeport
Bridgeport, Connecticut, 06610, United States
Hamden
Hamden, Connecticut, 06518, United States
Washington DC
Washington D.C., District of Columbia, 20422, United States
Jacksonville
Jacksonville, Florida, 32216, United States
Naples
Naples, Florida, 34102, United States
Pinellas Park
Pinellas Park, Florida, 33781, United States
Tampa
Tampa, Florida, 33614, United States
Atlanta
Atlanta, Georgia, 30322, United States
Idaho Falls
Idaho Falls, Idaho, 83404, United States
Burr Ridge
Burr Ridge, Illinois, 60527, United States
Chicago
Chicago, Illinois, 60637, United States
Evanston
Evanston, Illinois, 60201, United States
Maywood
Maywood, Illinois, 60153, United States
Indianapolis
Indianapolis, Indiana, 46202, United States
West Des Moines
West Des Moines, Iowa, 50266, United States
Shawnee
Shawnee Mission, Kansas, 66217, United States
New Orleans
New Orleans, Louisiana, 70121, United States
Boston
Boston, Massachusetts, 02115, United States
Detroit
Detroit, Michigan, 48202, United States
Royal Oak
Royal Oak, Michigan, 48073, United States
Rochester
Rochester, Minnesota, 55905, United States
St. Paul
Saint Paul, Minnesota, 55102, United States
Butte
Butte, Montana, 59701, United States
Morristown
Morristown, New Jersey, 07960, United States
Somers Point
Somers Point, New Jersey, 08244, United States
New York
New York, New York, 10016, United States
New York
New York, New York, 10021, United States
New York
New York, New York, 10029, United States
Bronx
The Bronx, New York, 10467, United States
Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Kinston
Kinston, North Carolina, 28501, United States
Pinehurst
Pinehurst, North Carolina, 28374, United States
Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Winston-Salem
Winston-Salem, North Carolina, 27157, United States
Cincinnati
Cincinnati, Ohio, 45267, United States
Poland
Poland, Ohio, 44514, United States
Portland
Portland, Oregon, 97239, United States
Providence
Providence, Rhode Island, 02904, United States
Nashville
Nashville, Tennessee, 37212, United States
San Antonio
San Antonio, Texas, 78229, United States
Ogden
Ogden, Utah, 84403, United States
Salt Lake City
Salt Lake City, Utah, 84124, United States
Annandale
Annandale, Virginia, 22003, United States
Charlottesville
Charlottesville, Virginia, 22908, United States
Seattle
Seattle, Washington, 98101, United States
Grafton
Grafton, Wisconsin, 53024, United States
Calgary
Calgary, Alberta, T2N 2T9, Canada
Halifax
Halifax, Nova Scotia, B3H4C5, Canada
London
London, Ontario, N6A 4V2, Canada
Toronto
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shrish Budree
- Organization
- Finch Therapeutics
Study Officials
- STUDY DIRECTOR
Zain Kassam, MD, MPH
Finch Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2018
First Posted
April 13, 2018
Study Start
May 1, 2018
Primary Completion
December 31, 2020
Study Completion
April 1, 2021
Last Updated
August 30, 2022
Results First Posted
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share