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

Sponsor

Immuron Ltd. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01466894

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis	Biological: IMM 124-E Biological: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Placebo tablets	Biological: Placebo Tablets orally twice daily for 24 weeks

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo

Placebo tablets

Biological: Placebo

Tablets orally twice daily for 24 weeks

Outcome Measures

Primary Outcome Measures

Safety outcome [28 weeks]
No unexpected treatment related SAEs throughout the participation period and the follow up period

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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