Beta Glucosylceramide for Treatment of NASH
1 other identifier
interventional
23
0 countries
N/A
Brief Summary
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2006
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedOctober 30, 2014
January 1, 2006
4.9 years
April 9, 2014
April 30, 2014
October 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Placebo
PLACEBO COMPARATORNormal saline administered orally daily as a placebo
Beta Glucosylceramide
ACTIVE COMPARATORBeta glucosylceramide administered orally daily
Interventions
Eligibility Criteria
You may qualify if:
- Biopsy proven NASH
You may not qualify if:
- Other therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Gadi Lalazar
- Organization
- HMO
Study Officials
- STUDY DIRECTOR
Yaron Ilan, M.D.
Hadassah Medical Organization
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 30, 2014
Study Start
January 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 30, 2014
Results First Posted
August 18, 2014
Record last verified: 2006-01