Beta Glucosylceramide for Treatment of NASH

NCT ID: NCT02126306

Last Updated: 2014-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Compliance Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Normal saline administered orally daily as a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline

Beta Glucosylceramide

Beta glucosylceramide administered orally daily

Group Type ACTIVE_COMPARATOR

Beta Glucosylceramide

Intervention Type DRUG

Beta Glucosylceramide

Interventions

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Beta Glucosylceramide

Beta Glucosylceramide

Intervention Type DRUG

Placebo

normal saline

Intervention Type DRUG

Other Intervention Names

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normal saline

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven NASH

Exclusion Criteria

* Other therapies
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaron Ilan, M.D.

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Other Identifiers

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YI1958

Identifier Type: -

Identifier Source: org_study_id

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