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Beta Glucosylceramide for Treatment of NASH

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ClinicalTrials.gov Identifier: NCT02126306
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : August 18, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Compliance Behavior
Interventions Drug: Beta Glucosylceramide
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Beta Glucosylceramide
Hide Arm/Group Description

Placebo

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

Beta Glucosylceramide 7.5 mg

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

Period Title: Overall Study
Started 10 13
Completed 10 13
Not Completed 0 0
Arm/Group Title Placebo Beta Glucosylceramide Total
Hide Arm/Group Description

Placebo

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

Beta Glucosylceramide

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

Total of all reporting groups
Overall Number of Baseline Participants 10 13 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
13
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
Female
3
  30.0%
3
  23.1%
6
  26.1%
Male
7
  70.0%
10
  76.9%
17
  73.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 10 participants 13 participants 23 participants
10 13 23
1.Primary Outcome
Title Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Beta Glucosylceramide
Hide Arm/Group Description:

Placebo

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo NAS score

Beta Glucosylceramide

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo NAS score

Overall Number of Participants Analyzed 10 13
Measure Type: Number
Unit of Measure: participants
10 13
Time Frame 40 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Beta Glucosylceramide
Hide Arm/Group Description

Placebo

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

Beta Glucosylceramide

Beta Glucosylceramide: Beta Glucosylceramide

placebo: placebo

All-Cause Mortality
Placebo Beta Glucosylceramide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Beta Glucosylceramide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Beta Glucosylceramide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Gadi Lalazar
Organization: HMO
Phone: 97226777337
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02126306     History of Changes
Other Study ID Numbers: YI1958
First Submitted: April 9, 2014
First Posted: April 30, 2014
Results First Submitted: April 30, 2014
Results First Posted: August 18, 2014
Last Update Posted: October 30, 2014