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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02126306
Other study ID # YI1958
Secondary ID
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


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
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