Trial | NCT01466894  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Dec 31
2012
Primary Completion
Dec 31
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Dec 06
2012
Estimate

Biological Placebo

Tablets orally twice daily for 24 weeks

Biological IMM 124-E

Tablets orally twice a day for 24 weeks

  • Other names: Bovine colostrum powder

IMM 124-E high dose Experimental

IMM 124-E 3600 mg per day

IMM 124-E low dose Experimental

IMM 124-E 1800 mg per day

Placebo Placebo Comparator

Placebo tablets

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
No Results Posted