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.
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.
Brief Title
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Categories
Completion Date
Completion Date Type
Actual
Conditions
Clostridium Difficile Infection
Recurrent Clostridium Difficile Infection
C. Diff
CDI
Recurrent C. Diff
rCDI
C. Difficile
Recurrent CDI
FMT
Fecal Microbiota
Fecal Transplant
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
Clostridium Difficile Infection
CP101
Crestovo
FMT
CDI
C. difficile
C. diff
Recurrent Clostridium Difficile Infection
Recurrent C. diff
Recurrent CDI
Finch
Fecal transplant
Fecal microbiota transplant
rCDI
Finch Therapeutics
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03497806
Org Class
Industry
Org Full Name
Finch Research and Development LLC.
Org Study Id
CP101-CDI-E02
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Outcome Time Frame
Up to Week 8
Outcome Measure
Occurence of Treatment Emergent Adverse Events (TEAEs)
Outcome Time Frame
Week 8
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to Week 24
Outcome Measure
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494