Trial Outcomes & Findings for Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (NCT NCT03497806)
NCT ID: NCT03497806
Last Updated: 2022-08-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Up to Week 8
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
CP101
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Week 8
STARTED
|
132
|
|
Week 8
COMPLETED
|
123
|
|
Week 8
NOT COMPLETED
|
9
|
|
Week 24
STARTED
|
123
|
|
Week 24
COMPLETED
|
112
|
|
Week 24
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
CP101
n=132 Participants
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Age, Continuous
|
66 Years
STANDARD_DEVIATION 15.83 • n=93 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
127 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=93 Participants
|
|
Total number of C. difficile Infection (CDI) episodes in previous 6 months
1
|
2 Participants
n=93 Participants
|
|
Total number of C. difficile Infection (CDI) episodes in previous 6 months
2
|
44 Participants
n=93 Participants
|
|
Total number of C. difficile Infection (CDI) episodes in previous 6 months
3
|
49 Participants
n=93 Participants
|
|
Total number of C. difficile Infection (CDI) episodes in previous 6 months
>3
|
37 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to Week 8Population: mITT
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 measures
| Measure |
CP101
n=132 Participants
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
|
106 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Safety population
Outcome measures
| Measure |
CP101
n=132 Participants
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Occurence of Treatment Emergent Adverse Events (TEAEs)
|
88 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: mITT
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 measures
| Measure |
CP101
n=132 Participants
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
|
104 Participants
|
Adverse Events
CP101
Serious events: 17 serious events
Other events: 97 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CP101
n=132 participants at risk
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
1/132 • Up to Week 24
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.76%
1/132 • Up to Week 24
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
2/132 • Up to Week 24
|
|
Cardiac disorders
Acute left ventricular failure
|
0.76%
1/132 • Up to Week 24
|
|
Cardiac disorders
Angina pectoris
|
0.76%
1/132 • Up to Week 24
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/132 • Up to Week 24
|
|
Cardiac disorders
Atrial flutter
|
0.76%
1/132 • Up to Week 24
|
|
Cardiac disorders
Bradycardia
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/132 • Up to Week 24
|
|
Gastrointestinal disorders
Abdominal pain
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.76%
1/132 • Up to Week 24
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.76%
1/132 • Up to Week 24
|
|
Infections and infestations
Clostridium difficile infection
|
0.76%
1/132 • Up to Week 24
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
2/132 • Up to Week 24
|
|
Infections and infestations
Osteomyelitis
|
0.76%
1/132 • Up to Week 24
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/132 • Up to Week 24
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.76%
1/132 • Up to Week 24
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.76%
1/132 • Up to Week 24
|
|
Metabolism and nutrition disorders
Dehydration
|
0.76%
1/132 • Up to Week 24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/132 • Up to Week 24
|
|
Nervous system disorders
Encephalopathy
|
0.76%
1/132 • Up to Week 24
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.76%
1/132 • Up to Week 24
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
1/132 • Up to Week 24
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/132 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
2/132 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/132 • Up to Week 24
|
|
Vascular disorders
Haematoma
|
0.76%
1/132 • Up to Week 24
|
|
Vascular disorders
Hypertensive emergency
|
0.76%
1/132 • Up to Week 24
|
|
Vascular disorders
Hypovolaemic shock
|
0.76%
1/132 • Up to Week 24
|
Other adverse events
| Measure |
CP101
n=132 participants at risk
Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
39.4%
52/132 • Up to Week 24
|
|
Gastrointestinal disorders
Abdominal pain
|
32.6%
43/132 • Up to Week 24
|
|
Gastrointestinal disorders
Defaecation urgency
|
25.0%
33/132 • Up to Week 24
|
|
Gastrointestinal disorders
Nausea
|
18.2%
24/132 • Up to Week 24
|
|
Gastrointestinal disorders
Abdominal distension
|
17.4%
23/132 • Up to Week 24
|
|
Gastrointestinal disorders
Abdominal tenderness
|
12.9%
17/132 • Up to Week 24
|
|
Gastrointestinal disorders
Anal incontinence
|
9.8%
13/132 • Up to Week 24
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
12/132 • Up to Week 24
|
|
Gastrointestinal disorders
Haematochezia
|
7.6%
10/132 • Up to Week 24
|
|
Infections and infestations
Urinary tract infection
|
5.3%
7/132 • Up to Week 24
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
24/132 • Up to Week 24
|
|
Metabolism and nutrition disorders
Dehydration
|
7.6%
10/132 • Up to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER