Clinical trial NCT01466894: Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Keywords: Nonalcoholic fatty liver disease
NAFLD
Fatty liver
NASH
Lead sponsor: Immuron Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety outcome
timeFrame: 28 weeks
Secondary outcomes:
measure: MRI liver fat quantitation
timeFrame: Baseline and 24 weeks
measure: ALT levels
timeFrame: Baseline and 24 weeks
measure: Liver enzyme improvement
timeFrame: Baseline and 24 weeks
measure: Lipid profile
timeFrame: Baseline and 24 weeks
measure: HbA1c
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
References: