Nonalcoholic SteatohepatitisPhase 2NCT01466894
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
A Phase 2 study testing IMM 124-E in people with Nonalcoholic Steatohepatitis, run by Immuron Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- IMM 124-E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- IMM 124-E, Placebo
- Keywords
- Nonalcoholic fatty liver disease, NAFLD, Fatty liver, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM 124-EBiological
Also called Bovine colostrum powder
Tablets orally twice a day for 24 weeks
PlaceboBiological
Tablets orally twice daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMM 124-E high dose | Experimental | IMM 124-E 3600 mg per day Receives: Biological: IMM 124-E |
| IMM 124-E low dose | Experimental | IMM 124-E 1800 mg per day Receives: Biological: IMM 124-E |
| Placebo | Placebo comparator | Placebo tablets Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
No unexpected treatment related SAEs throughout the participation period and the follow up period
Measured: 28 weeks
Secondary outcomes (5)
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
Measured: Baseline and 24 weeks
ALT levels
Normalization of alanine aminotransferase levels in patients with NASH from baseline to week 24
Measured: Baseline and 24 weeks
Liver enzyme improvement
Improvement in liver enzymes by 20% from baseline from baseline to week 24
Measured: Baseline and 24 weeks
Lipid profile
Improvement in lipid profile by 20% from baseline from baseline to week 24
Measured: Baseline and 24 weeks
HbA1c
Improvement in HBA1c by 0.5 % from baseline from baseline to week 24
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Sponsor administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immuron Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466894
- Sponsor's protocol ID
- NASH-Immuron-002
- Status last verified
- Dec 2012
- First submitted
- 2 Nov 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Dosing, Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT01466894
- Acronym / sponsor ID
- NASH-Immuron-002
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Nonalcoholic fatty liver disease, NAFLD, Fatty liver, NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor administrative decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Immuron Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMM 124-E high dose | Experimental | Biological: IMM 124-EIMM 124-E 3600 mg per day |
| IMM 124-E low dose | Experimental | Biological: IMM 124-EIMM 124-E 1800 mg per day |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM 124-EAlso: Bovine colostrum powderTablets orally twice a day for 24 weeks | Biological | IMM 124-E high dose, IMM 124-E low dose |
| PlaceboTablets orally twice daily for 24 weeks | Biological | Placebo |
Primary outcome
Safety outcome
Time frame: 28 weeks
No unexpected treatment related SAEs throughout the participation period and the follow up period
5 secondary outcomes
MRI liver fat quantitation
Time frame: Baseline and 24 weeks
ALT levels
Time frame: Baseline and 24 weeks
Liver enzyme improvement
Time frame: Baseline and 24 weeks
Lipid profile
Time frame: Baseline and 24 weeks
HbA1c
Time frame: Baseline and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM 124-E in people with Nonalcoholic Steatohepatitis, run by Immuron Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.