Beta Glucosylceramide for Treatment of NASH

Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis

Registry	NCT02126306
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	23 (Actual)
Sponsor	Hadassah Medical Organization (Other)
Conditions	Compliance Behavior
Interventions	Beta Glucosylceramide, Placebo (Drug)
Dates	start 2006-01-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2014-04-30, last updated 2014-10-30

-Summary

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.

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo	Normal saline administered orally daily as a placebo
Beta Glucosylceramide	Active comparator	Drug: Beta Glucosylceramide	Beta glucosylceramide administered orally daily

Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol [Total score from baseline compared with week 40.]: 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.

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Biopsy proven NASH

Exclusion Criteria:

* Other therapies

Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol (Primary), Number, participants: Placebo 10; Beta Glucosylceramide 13

Time frame: 40 weeks

Arm	Deaths	Serious adverse events	Other adverse events
Placebo	0	0/10 (0.0%)	0/10 (0.0%)
Beta Glucosylceramide	0	0/13 (0.0%)	0/13 (0.0%)

Public

To Read Reading Read