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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

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

Condition or disease Intervention/treatment Phase
Compliance Behavior Drug: Beta Glucosylceramide Drug: Placebo Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis
Study Start Date : January 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline administered orally daily as a placebo
Drug: Placebo
normal saline
Other Name: normal saline

Active Comparator: Beta Glucosylceramide
Beta glucosylceramide administered orally daily
Drug: Beta Glucosylceramide
Beta Glucosylceramide




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven NASH

Exclusion Criteria:

  • Other therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126306


Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Study Director: Yaron Ilan, M.D. Hadassah Medical Center

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02126306     History of Changes
Other Study ID Numbers: YI1958
First Posted: April 30, 2014    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: October 30, 2014
Last Verified: January 2006