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Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.
Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlequelTM | Experimental | AlequelTM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alequel | Drug | Alequel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improved in Disease Activity | 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaron Ilan, M.D. | Hadassah Medical Organization | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | AlequelTM 30 ng Once a Day Orally | AlequelTM 30 ng once a day orally Alequel: Alequel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AlequelTM | AlequelTM Alequel: Alequel |
| 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 Improved in Disease Activity | Number | participants | 15 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 | AlequelTM | AlequelTM Alequel: Alequel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elazar Rabbani | ENZO | 2125830100 | erabbani@enzo.com |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | 14 participants followed for improvement of disease | Number | participants |
|
| Crohn's disease activity index | On a sclae of 100 to 400, a decrease in the score suggests improvement of disease activity | Mean | Full Range | units on a scale |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
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| D007410 | Intestinal Diseases |