Beta Glucosylceramide for Treatment of NASH

Hadassah Medical Organization23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Compliance Behavior

Interventions

Beta GlucosylceramideDRUG

Beta Glucosylceramide

PlaceboDRUG

normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy proven NASH Exclusion Criteria: * Other therapies

Outcomes

Primary Outcomes

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.

Time frame: Total score from baseline compared with week 40.

Data from ClinicalTrials.gov

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