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Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal saline administered orally daily as a placebo |
|
| Beta Glucosylceramide | Active Comparator | Beta glucosylceramide administered orally daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta Glucosylceramide | Drug | Beta Glucosylceramide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol | Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made. Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included. | Total score from baseline compared with week 40. |
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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 | Placebo | Placebo Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo |
| FG001 | Beta Glucosylceramide | Beta Glucosylceramide 7.5 mg Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo |
| BG001 | Beta Glucosylceramide | Beta Glucosylceramide Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol | Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made. Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included. | Posted | Number | participants | Total score from baseline compared with week 40. |
|
40 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 Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gadi Lalazar | HMO | 97226777337 | lalazar@hadassah.org.il |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo |
| Drug |
normal saline |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo
Beta Glucosylceramide: Beta Glucosylceramide
placebo: placebo NAS score
| OG001 | Beta Glucosylceramide | Beta Glucosylceramide Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo NAS score |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Beta Glucosylceramide | Beta Glucosylceramide Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo | 0 | 13 | 0 | 13 |
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