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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020484-20 | EudraCT Number |
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The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| VP20621 Low Dose and Placebo | Experimental |
| |
| VP20621 High Dose and Placebo | Experimental |
| |
| VP20621 High Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VP20621 | Biological | VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. | Baseline up to 7 days after the last dose of study drug (up to Week 3) |
| Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3 | After study drug administration period (14 days) through Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clostridium Difficile Infection (CDI) Recurrence | CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modesto | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25942722 | Derived | Gerding DN, Meyer T, Lee C, Cohen SH, Murthy UK, Poirier A, Van Schooneveld TC, Pardi DS, Ramos A, Barron MA, Chen H, Villano S. Administration of spores of nontoxigenic Clostridium difficile strain M3 for prevention of recurrent C. difficile infection: a randomized clinical trial. JAMA. 2015 May 5;313(17):1719-27. doi: 10.1001/jama.2015.3725. |
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Of the 213 participants formally screened to participate in this study, 168 participants were treated. Five participants were randomized but not treated and 40 participants were screen failures.
This study was conducted at a total of 44 investigative sites [United states (US)=33, Canada=4, and Europe=7], and 3 of the 33 US sites did not enroll any participants (each had 1 screen failure).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14. |
| FG001 | VP 20621 Low Dose and Placebo | VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| VP20621 | Biological | VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days |
|
| Placebo | Other | 10 mL placebo once daily for 14 days |
|
| VP20621 | Biological | VP20621 as oral liquid once daily for 14 days |
|
| Baseline (Day 1) up to Week 6 |
| Number of Participants With Use of Antibacterial Treatment for CDI | Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection". | Baseline (Day 1) up to Week 6 |
| Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools | Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed. | Baseline (Day 1) up to Week 6 |
| Time to First CDI Recurrence | CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable. | Baseline (Day 1) up to Week 6 |
| Palm Desert |
| California |
| United States |
| Sacramento | California | United States |
| Aurora | Colorado | United States |
| Hartford | Connecticut | United States |
| Bay Pines | Florida | United States |
| Jacksonville | Florida | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| Maywood | Illinois | United States |
| Anderson | Indiana | United States |
| Lafayette | Indiana | United States |
| Lexington | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Chevy Chase | Maryland | United States |
| Detroit | Michigan | United States |
| Grosse Pointe Woods | Michigan | United States |
| Novi | Michigan | United States |
| Royal Oak | Michigan | United States |
| Sault Ste. Marie | Michigan | United States |
| Rochester | Minnesota | United States |
| St Louis | Missouri | United States |
| Butte | Montana | United States |
| Omaha | Nebraska | United States |
| Albany | New York | United States |
| New York | New York | United States |
| North Massapequa | New York | United States |
| Syracuse | New York | United States |
| The Bronx | New York | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cleveland | Ohio | United States |
| Lima | Ohio | United States |
| Toledo | Ohio | United States |
| Lancaster | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Houston | Texas | United States |
| Temple | Texas | United States |
| Salt Lake City | Utah | United States |
| Winchester | Virginia | United States |
| Tacoma | Washington | United States |
| Aalst | Belgium |
| Brussels | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Calgary | Alberta | Canada |
| Hamilton | Ontario | Canada |
| Chicoutimi | Quebec | Canada |
| Montreal | Quebec | Canada |
| Trois-Rivières | Quebec | Canada |
| Cologne | Germany |
| Hanover | Germany |
| Leipzig | Germany |
| Wilhelmshaven | Germany |
| Seville | Andalusia | Spain |
| Barcelona | Catalonia | Spain |
| Majadahonda | Communidad de Madrid | Spain |
| Lugano | Switzerland |
| FG002 | VP 20621 High Dose and Placebo | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14. |
| FG003 | VP 20621 High Dose | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14. |
| BG001 | VP 20621 Low Dose and Placebo | VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14. |
| BG002 | VP 20621 High Dose and Placebo | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14. |
| BG003 | VP 20621 High Dose | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14. |
| BG004 | Total | Total of all reporting groups |
| 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 |
|
| 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 Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. | Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug. | Posted | Number | Participants | Baseline up to 7 days after the last dose of study drug (up to Week 3) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3 | ITT-S population. | Posted | Number | Participants | After study drug administration period (14 days) through Week 6 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clostridium Difficile Infection (CDI) Recurrence | CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. | ITT-S population. | Posted | Number | Participants | Baseline (Day 1) up to Week 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Use of Antibacterial Treatment for CDI | Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection". | ITT-S population. | Posted | Number | Participants | Baseline (Day 1) up to Week 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools | Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed. | ITT-S population. | Posted | Number | Participants | Baseline (Day 1) up to Week 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to First CDI Recurrence | CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable. | ITT-S population | Posted | Median | Full Range | days | Baseline (Day 1) up to Week 6 |
|
Up to 26 Weeks
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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 | Placebo | Placebo: 10 mL placebo once daily for 14 days | 8 | 43 | 37 | 43 | ||
| EG001 | VP20621 Low Dose and Placebo | VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days | 5 | 41 | 31 | 41 | ||
| EG002 | VP20621 High Dose and Placebo | VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days | 8 | 43 | 34 | 43 | ||
| EG003 | VP20621 High Dose | VP20621: VP20621 as oral liquid once daily for 14 days | 6 | 41 | 34 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cerebrovascular arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Non-Cardiac chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dependence | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Participants with treatment-emergent SAEs |
|
|
|
|
| OG003 | VP 20621 High Dose | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14. |
|
|
|
|
|
|
|
|
|
VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
| OG003 | VP 20621 High Dose | VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14. |
|
|