Beta Glucosylceramide for Treatment of NASH

Compliance Behavior Clinical Trial

Official title:

Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126306
• Other study ID #: YI1958
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 9, 2014
• Last updated: October 22, 2014
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Biopsy proven NASH

Exclusion Criteria:

• Other therapies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compliance Behavior

Intervention

Drug:
• Beta Glucosylceramide
Beta Glucosylceramide
• Placebo
normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Total score from baseline compared with week 40.	Yes