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

NCT01466894 | Withdrawn Phase 2

• 1 other identifier: NASH-Immuron-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Safety outcome

  No unexpected treatment related SAEs throughout the participation period and the follow up period

  28 weeks

Secondary Outcomes (5)

• MRI liver fat quantitation

  Baseline and 24 weeks

• ALT levels

  Baseline and 24 weeks

• Liver enzyme improvement

  Baseline and 24 weeks

• Lipid profile

  Baseline and 24 weeks

• HbA1c

  Baseline and 24 weeks

Study Arms (3)

IMM 124-E high dose

EXPERIMENTAL

IMM 124-E 3600 mg per day

Biological: IMM 124-E

IMM 124-E low dose

EXPERIMENTAL

IMM 124-E 1800 mg per day

Biological: IMM 124-E

Placebo

PLACEBO COMPARATOR

Placebo tablets

Biological: Placebo

Interventions

IMM 124-E BIOLOGICAL

Tablets orally twice a day for 24 weeks

Also known as: Bovine colostrum powder

IMM 124-E high dose; IMM 124-E low dose

Placebo BIOLOGICAL

Tablets orally twice daily for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immuron Ltd.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 8, 2011
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 6, 2012

Record last verified: 2012-12