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

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ClinicalTrials.gov Identifier: NCT01466894
Recruitment Status : Withdrawn (Sponsor administrative decision)
First Posted : November 8, 2011
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Immuron Ltd.

Tracking Information
First Submitted Date  ICMJE November 2, 2011
First Posted Date  ICMJE November 8, 2011
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
Safety outcome [ Time Frame: 28 weeks ]
No unexpected treatment related SAEs throughout the participation period and the follow up period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01466894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2011)
  • MRI liver fat quantitation [ Time Frame: 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 [ Time Frame: Baseline and 24 weeks ]
    Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24
  • Liver enzyme improvement [ Time Frame: Baseline and 24 weeks ]
    Improvement in liver enzymes by 20% from baseline from baseline to week 24
  • Lipid profile [ Time Frame: Baseline and 24 weeks ]
    Improvement in lipid profile by 20% from baseline from baseline to week 24
  • HbA1c [ Time Frame: Baseline and 24 weeks ]
    Improvement in HBA1c by 0.5 % from baseline from baseline to week 24
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Dosing, Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Biological: IMM 124-E
    Tablets orally twice a day for 24 weeks
    Other Name: Bovine colostrum powder
  • Biological: Placebo
    Tablets orally twice daily for 24 weeks
Study Arms  ICMJE
  • Experimental: IMM 124-E high dose
    IMM 124-E 3600 mg per day
    Intervention: Biological: IMM 124-E
  • Experimental: IMM 124-E low dose
    IMM 124-E 1800 mg per day
    Intervention: Biological: IMM 124-E
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2011)
120
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01466894
Other Study ID Numbers  ICMJE NASH-Immuron-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immuron Ltd.
Study Sponsor  ICMJE Immuron Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immuron Ltd.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP