Beta Glucosylceramide for Treatment of NASH

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

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Key information

Conditions

Compliance Behavior Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Biopsy proven NASH

Exclusion criteria

Other therapies

Treatment and study plan

Beta Glucosylceramide

Drug

Beta Glucosylceramide

Placebo

Drug

normal saline

Other names: normal saline

Primary outcomes

Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Apr 30, 2014
Registry last updated: Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed