Beta Glucosylceramide for Treatment of NASH

Phase 1

Completed

• Conditions: Compliance Behavior
• Interventions: Drug: Placebo; Drug: Beta Glucosylceramide

• Registration Number: NCT02126306
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.

Detailed Description

Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Results First Submitted: 2014-04-30
• Results First Submitted QC: 2014-08-03
• Results First Posted: 2014-08-18
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Biopsy proven NASH

Exclusion Criteria

• Other therapies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline administered orally daily as a placebo
Beta Glucosylceramide	Beta Glucosylceramide	Beta glucosylceramide administered orally daily

Primary Outcome Measures

Name	Time	Method
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.