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Sponsor's decision
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Other | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bezlotoxumab | Biological | Bezlotoxumab infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrent C. Diff Infection at 90 Days | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | 90 days |
| Number of Participants With Recurrent C. Diff Infection at 12 Months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | 12 months |
| Number of Participants With Recurrent C. Diff Infection at 24 Months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab. | 90 days |
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Binion, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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Randomly the study treatment will be offered to 50 patients.
Patients who are part of the IBD Registry and have a defined IBD diagnosis and CDI will be approached to be consented for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Bezlotuxumab | Single arm Bezlotoxumab infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Bezlotuxumab | Single arm Bezlotoxumab infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Recurrent C. Diff Infection at 90 Days | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | Posted | Count of Participants | Participants | 90 days |
|
|
AE data was collected through study completion, an average of 54 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 | Open Label Bezlotuxumab | Single arm Bezlotoxumab infusion | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G. Binion | University of Pittsburgh | 412-647-4194 | binion@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2019 | Apr 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2023 | Apr 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000613978 | bezlotoxumab |
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Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab |
| 12 months |
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab | 24 months |
| Quality of Life and Disease Activity Scores of Participants at Study Baseline | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | Index visit |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | 90 Days |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | 12 months |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | 24 months |
| Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days. | 90 Days |
| Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months | 12 months |
| Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months | 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IBD Type | Number | participants |
|
|
| Primary | Number of Participants With Recurrent C. Diff Infection at 12 Months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Number of Participants With Recurrent C. Diff Infection at 24 Months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Quality of Life and Disease Activity Scores of Participants at Study Baseline | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | 14 CD, 5 UC | Posted | Mean | Standard Deviation | score on a scale | Index visit |
|
|
|
| Secondary | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | CD=12, UC=5 | Posted | Mean | Standard Deviation | score on a scale | 90 Days |
|
|
|
| Secondary | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | CD=7, UC=1 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission. | CD=4, UC=1 | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
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|
| Secondary | Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days. | Posted | Number | Ocurrences | 90 Days |
|
|
|
| Secondary | Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months | Posted | Number | Ocurrences | 12 months |
|
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| Secondary | Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months | Posted | Number | Ocurrences | 24 months |
|
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|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| UCAI |
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| UCAI |
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| UCAI |
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| UCAI |
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