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

This study has been withdrawn prior to enrollment.
(Sponsor administrative decision)
Sponsor:
Information provided by (Responsible Party):
Immuron Ltd.
ClinicalTrials.gov Identifier:
NCT01466894
First received: November 2, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Nonalcoholic Steatohepatitis
Biological: IMM 124-E
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Immuron Ltd.:

Primary Outcome Measures:
  • Safety outcome [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    No unexpected treatment related SAEs throughout the participation period and the follow up period


Secondary Outcome Measures:
  • MRI liver fat quantitation [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24

  • Liver enzyme improvement [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Improvement in liver enzymes by 20% from baseline from baseline to week 24

  • Lipid profile [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Improvement in lipid profile by 20% from baseline from baseline to week 24

  • HbA1c [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Improvement in HBA1c by 0.5 % from baseline from baseline to week 24


Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Bovine colostrum powder
Placebo Comparator: Placebo
Placebo tablets
Biological: Placebo
Tablets orally twice daily for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Immuron Ltd.
ClinicalTrials.gov Identifier: NCT01466894     History of Changes
Other Study ID Numbers: NASH-Immuron-002
Study First Received: November 2, 2011
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
Australia: Therapeutic Goods Administration

Keywords provided by Immuron Ltd.:
Nonalcoholic fatty liver disease
NAFLD
Fatty liver
NASH

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014