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Trial Outcomes & Findings for Beta Glucosylceramide for Treatment of NASH (NCT NCT02126306)

NCT ID: NCT02126306

Last Updated: 2014-10-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Total score from baseline compared with week 40.

Results posted on

2014-10-30

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo
Placebo Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo
Beta Glucosylceramide
Beta Glucosylceramide 7.5 mg Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo
Overall Study
STARTED
10
13
Overall Study
COMPLETED
10
13
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beta Glucosylceramide for Treatment of NASH

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=10 Participants
Placebo Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo
Beta Glucosylceramide
n=13 Participants
Beta Glucosylceramide Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=99 Participants
13 Participants
n=107 Participants
23 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Sex: Female, Male
Male
7 Participants
n=99 Participants
10 Participants
n=107 Participants
17 Participants
n=206 Participants
Region of Enrollment
Israel
10 participants
n=99 Participants
13 participants
n=107 Participants
23 participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Placebo Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo NAS score
Beta Glucosylceramide
n=13 Participants
Beta Glucosylceramide Beta Glucosylceramide: Beta Glucosylceramide placebo: placebo NAS score
Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol
10 participants
13 participants

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Beta Glucosylceramide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Gadi Lalazar

HMO

Phone: 97226777337

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place