Beta Glucosylceramide for Treatment of NASH

Hadassah Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Compliance Behavior

Treatments: Drug: Placebo; Drug: Beta Glucosylceramide

Study type: Interventional

Funder types: Other

Identifiers

NCT02126306

YI1958

Details and patient eligibility

About

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

Full description

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven NASH

Exclusion criteria

• Other therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal saline administered orally daily as a placebo

Treatment:

Drug: Placebo

Beta Glucosylceramide

Active Comparator group

Description:

Beta glucosylceramide administered orally daily

Treatment:

Drug: Beta Glucosylceramide