Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | December 2012 |
| End Date: | December 2013 |
| Contact: | Yaron Ilan, MD |
| Email: | ILAN@hadassah.org.il |
| Phone: | +972-2-6777111 |
A Randomized, Double-Blind, Placebo-Controlled Dosing, Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
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.
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
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