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

Primary Purpose

Nonalcoholic Steatohepatitis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

IMM 124-E

Placebo

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring Nonalcoholic fatty liver disease, NAFLD, Fatty liver, NASH

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

IMM 124-E high dose

IMM 124-E low dose

Placebo

Arm Description

IMM 124-E 3600 mg per day

IMM 124-E 1800 mg per day

Placebo tablets

Outcomes

Primary Outcome Measures

Safety outcome

No unexpected treatment related SAEs throughout the participation period and the follow up period

Secondary Outcome Measures

MRI liver fat quantitation

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

Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24

Liver enzyme improvement

Improvement in liver enzymes by 20% from baseline from baseline to week 24

Lipid profile

Improvement in lipid profile by 20% from baseline from baseline to week 24

HbA1c

Improvement in HBA1c by 0.5 % from baseline from baseline to week 24

Full Information

NCT ID

NCT01466894

First Posted

November 2, 2011

Last Updated

December 4, 2012

Sponsor

Immuron Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01466894

Brief Title

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

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor administrative decision

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immuron Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic fatty liver disease, NAFLD, Fatty liver, NASH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMM 124-E high dose

Arm Type

Experimental

Arm Description

IMM 124-E 3600 mg per day

Arm Title

IMM 124-E low dose

Arm Type

Experimental

Arm Description

IMM 124-E 1800 mg per day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets

Intervention Type

Biological

Intervention Name(s)

IMM 124-E

Other Intervention Name(s)

Bovine colostrum powder

Intervention Description

Tablets orally twice a day for 24 weeks

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Tablets orally twice daily for 24 weeks

Primary Outcome Measure Information:

Title

Safety outcome

Description

No unexpected treatment related SAEs throughout the participation period and the follow up period

Time Frame

28 weeks

Secondary Outcome Measure Information:

Title

MRI liver fat quantitation

Description

Improvement in MRI fat quantification as determined by a decrease in the fat content by 5% or more from baseline to week 24

Time Frame

Baseline and 24 weeks

Title

ALT levels

Description

Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24

Time Frame

Baseline and 24 weeks

Title

Liver enzyme improvement

Description

Improvement in liver enzymes by 20% from baseline from baseline to week 24

Time Frame

Baseline and 24 weeks

Title

Lipid profile

Description

Improvement in lipid profile by 20% from baseline from baseline to week 24

Time Frame

Baseline and 24 weeks

Title

HbA1c

Description

Improvement in HBA1c by 0.5 % from baseline from baseline to week 24

Time Frame

Baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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