Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (PRISM-EXT)

August 10, 2022 updated by: Finch Research and Development LLC.

PRISM-EXT: An 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H4C5
        • Halifax
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • London
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85054
        • Scottsdale
    • California
      • Los Angeles, California, United States, 90095
        • Los Angeles
      • Murrieta, California, United States, 92563
        • Murrieta
      • Oakland, California, United States, 94705
        • Oakland
      • San Diego, California, United States, 92123
        • San Diego
      • San Francisco, California, United States, 94115
        • San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Aurora
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport
      • Hamden, Connecticut, United States, 06518
        • Hamden
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington DC
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville
      • Naples, Florida, United States, 34102
        • Naples
      • Pinellas Park, Florida, United States, 33781
        • Pinellas Park
      • Tampa, Florida, United States, 33614
        • Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Atlanta
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Burr Ridge
      • Chicago, Illinois, United States, 60637
        • Chicago
      • Evanston, Illinois, United States, 60201
        • Evanston
      • Maywood, Illinois, United States, 60153
        • Maywood
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indianapolis
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • West Des Moines
    • Kansas
      • Shawnee Mission, Kansas, United States, 66217
        • Shawnee
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Detroit
      • Royal Oak, Michigan, United States, 48073
        • Royal Oak
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Rochester
      • Saint Paul, Minnesota, United States, 55102
        • St. Paul
    • Montana
      • Butte, Montana, United States, 59701
        • Butte
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown
      • Somers Point, New Jersey, United States, 08244
        • Somers Point
    • New York
      • Bronx, New York, United States, 10467
        • Bronx
      • New York, New York, United States, 10016
        • New York
      • New York, New York, United States, 10021
        • New York
      • New York, New York, United States, 10029
        • New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Chapel Hill
      • Kinston, North Carolina, United States, 28501
        • Kinston
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst
      • Winston-Salem, North Carolina, United States, 27103
        • Winston-Salem
      • Winston-Salem, North Carolina, United States, 27157
        • Winston-Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Cincinnati
      • Poland, Ohio, United States, 44514
        • Poland
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Providence
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Nashville
    • Texas
      • San Antonio, Texas, United States, 78229
        • San Antonio
    • Utah
      • Ogden, Utah, United States, 84403
        • Ogden
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake City
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Annandale
      • Charlottesville, Virginia, United States, 22908
        • Charlottesville
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle
    • Wisconsin
      • Grafton, Wisconsin, United States, 53024
        • Grafton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Ability to provide written informed consent;
  2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI
  3. An outpatient prior to Treatment
  4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period.

Exclusion Criteria:

  1. Pregnant, breast-feeding, or considering becoming pregnant during the study
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: 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 Names:
  • Full-Spectrum Microbiota™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Time Frame: Up to Week 8
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)
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Time Frame: Up to Week 24
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 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Finch Research and Development LLC.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medpace, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zain Kassam, MD, MPH, Finch Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP101-CDI-E02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clostridium Difficile Infection

Clinical Trials on CP101

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings