Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
NCT ID: NCT03497806
Last Updated: 2022-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2018-05-01
2021-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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High Dose CP101
The 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.
CP101
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.
Interventions
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CP101
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.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
6. Major intra-abdominal surgery within the past 60 days prior to Screening
7. 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
8. History of total colectomy/ileostomy or bariatric surgery
9. Planned hospitalization or invasive surgery during the study
10. Severe acute illness unrelated to CDI
18 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Finch Research and Development LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Zain Kassam, MD, MPH
Role: STUDY_DIRECTOR
Finch Therapeutics
Locations
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Scottsdale
Scottsdale, Arizona, United States
Los Angeles
Los Angeles, California, United States
Murrieta
Murrieta, California, United States
Oakland
Oakland, California, United States
San Diego
San Diego, California, United States
San Francisco
San Francisco, California, United States
Aurora
Aurora, Colorado, United States
Bridgeport
Bridgeport, Connecticut, United States
Hamden
Hamden, Connecticut, United States
Washington DC
Washington D.C., District of Columbia, United States
Jacksonville
Jacksonville, Florida, United States
Naples
Naples, Florida, United States
Pinellas Park
Pinellas Park, Florida, United States
Tampa
Tampa, Florida, United States
Atlanta
Atlanta, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Burr Ridge
Burr Ridge, Illinois, United States
Chicago
Chicago, Illinois, United States
Evanston
Evanston, Illinois, United States
Maywood
Maywood, Illinois, United States
Indianapolis
Indianapolis, Indiana, United States
West Des Moines
West Des Moines, Iowa, United States
Shawnee
Shawnee Mission, Kansas, United States
New Orleans
New Orleans, Louisiana, United States
Boston
Boston, Massachusetts, United States
Detroit
Detroit, Michigan, United States
Royal Oak
Royal Oak, Michigan, United States
Rochester
Rochester, Minnesota, United States
St. Paul
Saint Paul, Minnesota, United States
Butte
Butte, Montana, United States
Morristown
Morristown, New Jersey, United States
Somers Point
Somers Point, New Jersey, United States
New York
New York, New York, United States
New York
New York, New York, United States
New York
New York, New York, United States
Bronx
The Bronx, New York, United States
Chapel Hill
Chapel Hill, North Carolina, United States
Kinston
Kinston, North Carolina, United States
Pinehurst
Pinehurst, North Carolina, United States
Winston-Salem
Winston-Salem, North Carolina, United States
Winston-Salem
Winston-Salem, North Carolina, United States
Cincinnati
Cincinnati, Ohio, United States
Poland
Poland, Ohio, United States
Portland
Portland, Oregon, United States
Providence
Providence, Rhode Island, United States
Nashville
Nashville, Tennessee, United States
San Antonio
San Antonio, Texas, United States
Ogden
Ogden, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Annandale
Annandale, Virginia, United States
Charlottesville
Charlottesville, Virginia, United States
Seattle
Seattle, Washington, United States
Grafton
Grafton, Wisconsin, United States
Calgary
Calgary, Alberta, Canada
Halifax
Halifax, Nova Scotia, Canada
London
London, Ontario, Canada
Toronto
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP101-CDI-E02
Identifier Type: -
Identifier Source: org_study_id
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