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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose CP101 | Experimental | The active ingredient of CP101, Full-Spectrum Microbiotaâ„¢, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP101 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Absence of Recurrence Through Week 24 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 24 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zain Kassam, MD, MPH | Finch Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Scottsdale | Arizona | 85054 | United States | ||
| Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | CP101 | Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 8 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2019 | Jun 28, 2022 |
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|
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| Week 24 |
|
Modified Intent to Treat (mITT) population
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| ID | Title | Description |
|---|---|---|
| BG000 | CP101 | Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total number of C. difficile Infection (CDI) episodes in previous 6 months | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT | Posted | Count of Participants | Participants | Up to Week 8 |
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| Primary | Occurence of Treatment Emergent Adverse Events (TEAEs) | Safety population | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Absence of Recurrence Through Week 24 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. | mITT | Posted | Count of Participants | Participants | Up to Week 24 |
|
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Up to Week 24
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP101 | Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota | 1 | 132 | 17 | 132 | 97 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | Systematic Assessment |
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| Rectal ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative fever | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Defaecation urgency | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | Systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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The disclosure restrictions on the PI are: (i) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to eighteen months from the lock-down of all study data and (ii) the sponsor can require the removal of its confidential information from results communications and may delay release for a period of up to 60 days for the purpose of filing patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shrish Budree | Finch Therapeutics | (857) 322-4646 | 646 | sbudree@finchtherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2021 | Jun 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D020790 | Diabetes Insipidus, Neurogenic |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3 |
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| >3 |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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