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

A Randomized, Double-Blind, Placebo-Controlled Dosing, Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Nonalcoholic Steatohepatitis
• Intervention / Treatment: Biological: IMM 124-E; Biological: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Placebo tablets	Biological: Placebo; Tablets orally twice daily for 24 weeks
EXPERIMENTAL: IMM 124-E high dose; IMM 124-E 3600 mg per day	Biological: IMM 124-E; Tablets orally twice a day for 24 weeks; Other Names: Bovine colostrum powder
EXPERIMENTAL: IMM 124-E low dose; IMM 124-E 1800 mg per day	Biological: IMM 124-E; Tablets orally twice a day for 24 weeks; Other Names: Bovine colostrum powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	No unexpected treatment related SAEs throughout the participation period and the follow up period	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI liver fat quantitation	Improvement in MRI fat quantification as determined by a decrease in the fat content by 5% or more from baseline to week 24	Baseline and 24 weeks
ALT levels	Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24	Baseline and 24 weeks
Liver enzyme improvement	Improvement in liver enzymes by 20% from baseline from baseline to week 24	Baseline and 24 weeks
Lipid profile	Improvement in lipid profile by 20% from baseline from baseline to week 24	Baseline and 24 weeks
HbA1c	Improvement in HBA1c by 0.5 % from baseline from baseline to week 24	Baseline and 24 weeks

Collaborators and Investigators

• Sponsor: Immuron Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: November 2, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (ESTIMATE): November 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: NAFLD; NASH; Nonalcoholic fatty liver disease; Fatty liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NASH-Immuron-002