Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis

NCT ID: NCT01466894

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

Brief Summary

This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after completion of treatment.

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic fatty liver disease; NAFLD; Fatty liver; NASH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IMM 124-E high dose

IMM 124-E 3600 mg per day

Group Type: EXPERIMENTAL

IMM 124-E

Intervention Type: BIOLOGICAL

Tablets orally twice a day for 24 weeks

IMM 124-E low dose

IMM 124-E 1800 mg per day

Group Type: EXPERIMENTAL

IMM 124-E

Intervention Type: BIOLOGICAL

Tablets orally twice a day for 24 weeks

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Tablets orally twice daily for 24 weeks

Interventions

IMM 124-E

Tablets orally twice a day for 24 weeks

Intervention Type: BIOLOGICAL

Placebo

Tablets orally twice daily for 24 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

Bovine colostrum powder

Eligibility Criteria

Inclusion Criteria

• Men and women age 18 to 75 years (inclusive)
• Subjects with biopsy proven NASH (NAS ≥ 4) within one year prior to screening
• Elevated liver enzymes at screening and at least once within past 6 months (ALT > 30 women, ALT > 40 men)
• Normal or only slightly impaired synthetic liver function (serum albumin >3.5gm%, INR 0.8-1.5)
• BMI 18 to 40 (inclusive)
• Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study
• Women of child bearing potential must be using adequate contraception

Exclusion Criteria

• Cow milk allergy or lactose intolerance
• Excessive alcohol use (Women > 20 grams/day, Men > 40 grams/day).
• Current treatment with Insulin or Incretins
• Decompensated liver disease
• Other or concomitant cause of liver disease (viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease)
• Subjects who known to be HIV positive
• Subjects who have undergone surgery within the last 3 months
• Subjects who have had a prior gastrointestinal surgery
• Subjects who have a history of Inflammatory Bowel Disease
• Subjects who are receiving an elemental diet or parenteral nutrition
• Subjects with an infectious, immune-mediated or active malignant disease (during the last 3 months)
• Subjects with known clinically significant systemic disease
• Subjects treated with other anti-NASH therapy(s) - thiazolidinediones, vitamin E, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies and probiotics) - within 3 months of the liver biopsy
• Subjects who have been treated with any type of immune modulatory drug, including systemic steroids or NSAIDs, within the last 3 months
• Subjects who have received either Immuron, 6-MP, Methotrexate, Cyclosporine, anti-TNF alpha therapies (Infliximab, Adalimumab, Etanercept) or anti-integrin therapies (namixilab) within the past 12 months
• Known history of drug or alcohol abuse, including positive urinary drugs of abuse screen at the screening visit
• Subjects who are pregnant as confirmed on screening test
• Any acute medical situation (e.g. acute infection) within 48 hours of study start that is considered of significance by the Principal Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immuron Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

United States

Other Identifiers

NASH-Immuron-002

Identifier Type: -

Identifier Source: org_study_id