Status:
WITHDRAWN
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
Lead Sponsor:
Immuron Ltd.
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01466894
Start Date
December 1 2012
End Date
December 1 2013
Last Update
December 6 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.