Hepatitis, AlcoholicPhase 2TREATNCT01968382
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
A Phase 2 study testing IMM 124-E (Hyperimmune Bovine Colostrum) in people with Hepatitis, Alcoholic, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH). IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatitis, Alcoholic
- What is being tested?
- IMM 124-E (Hyperimmune Bovine Colostrum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to 22 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholic hepatitis
- Men and women age 21 and above
- MELD >= 20 but <=28
- About to initiate prednisolone treatment, < 7 days of steroid treatment, or treatment naive.
- Actively consuming alcohol within 6 weeks of entry into the study
- Willing and able to comply with study requirements (including contraception)
- Subjects or their legally authorized representative (LAR) who have provided voluntary written informed consent.
Who cannot join
- Failure to obtain informed consent
- Subjects who are known to be HIV positive
- Active infection or sepsis (pneumonia by X-ray, positive blood or urine culture) or multi-organ failure
- Other or concomitant liver disease present: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
- Cow milk allergy or severe lactose intolerance
- Active GI bleeding
Show all 14Show fewer
- Untreated spontaneous bacterial peritonitis based on >250 polymorphonuclear cells or positive culture
- Acute kidney injury at time of randomization with Creatinine > 1.5 md/dL
- Evidence of acute pancreatitis (by imaging and lipase) or biliary obstruction (dilated bile ducts)
- Subjects who are pregnant or lactating
- Significant systemic or major illness, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
- Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week immediately prior to the time of entry into the study.
- Any patient who has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University
Indianapolis, Indiana, 46202
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety and Efficacy Study of IMM 124-E (Hyperimmune Bovine Colostrum) for Patients With Severe Alcoholic Hepatitis
Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH).
IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.
Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm 124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on steroids.
Read the detailed description
Subjects with severe alcoholic hepatitis (20=> MELD <=28) about to receive prednisolone (40 mg/day x 28 days) will be randomized 1:1:1 to additionally receive either one of two doses of IMM 124-E (2400 mg/day or 4800 mg/day) orally or placebo for the same duration. Standard of care nutrition support and alcohol cessation recommendations will be provided to all subjects. Alcohol withdrawal will be managed per standard of care. Subjects who meet Lille criteria for failure of treatment on day 7 or side effects requiring discontinuation of steroids will be removed from the study. The primary endpoint is a decrease in plasma endotoxin levels.
The secondary endpoints will include:
- Mechanistic endpoints: TNF-α, immune-inflammatory markers, microbiome-metagenome
- Efficacy-related: number of subjects meeting Lille failure criteria at day 7 , mortality (at 30 days, 90 days, and 180 days), time to drop in conjugated bilirubin by 50%, bile acids, liver function tests, change in MELD, and sequential organ failure
- Safety related: tolerability, adverse events.
- Conditions
- Hepatitis, Alcoholic
- Being tested
- IMM 124-E (Hyperimmune Bovine Colostrum), Placebo (High protein milk powder)
- Keywords
- IMM 124-E, Bovine Colostrum, Alcoholic, Hepatitis, LPS, Hyper-immune
- Medical subject headings
- Hepatitis, Alcoholic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM 124-E (Hyperimmune Bovine Colostrum)Drug
Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder)Drug
Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
| Study group | Role | What they receive |
|---|---|---|
| IMM 124-E 2400 mg/day | Experimental | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. Receives: Drug: IMM 124-E (Hyperimmune Bovine Colostrum); Drug: Placebo (High protein milk powder) |
| IMM 124-E 4800 mg/day | Experimental | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. Receives: Drug: IMM 124-E (Hyperimmune Bovine Colostrum) |
| Placebo (High protein milk powder) | Placebo comparator | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. Receives: Drug: Placebo (High protein milk powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Safety Endpoints
Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Measured: 30 Days
Combined Kidney, Brain, and Lung Safety Endpoints
Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Measured: 30 Days
Infection Safety Endpoints
Number of incidents of sepsis.
Measured: 30 Days
Other Safety Endpoints
Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
Measured: 30 Days
Secondary outcomes (9)
Bowel Gastrointestinal Safety Endpoints
Number of participants who experience diarrhea
Measured: 30 Days
Change in Circulating Endotoxin Levels
Changes in endotoxin levels as measured using a standard blood assay
Measured: Baseline, day 28
Lille Model Score
Number of participants who meet Lille criteria indicating failure to respond to treatment
Measured: 7 days
Mortality
Number of deaths due to any cause
Measured: 180 days
Change in Liver Function
Model for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function.
Measured: 90 days
SOFA Score
SOFA is a single score based on patient status of six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status.
Measured: 30 days
Change in Serum Bile Acids
Serum bile acids levels as measured using standard blood serum assay
Measured: Baseline to 90 days
Time to 50% Drop in Bilirubin
Length of time to a drop in bilirubin of 50% measured in days
Measured: 180 days
Cytokine Data
Changes in cytokine profile across study arms at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startDec 2014
- Primary completion22 Dec 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis, AlcoholicStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Immuron Ltd.
- Responsible party
- Sponsor
- Investigators
- Arun J Sanyal, MBBS MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968382
- Sponsor's protocol ID
- HM20000157
- Other IDs
- U01AA021891, IMM-124-E
- Acronym
- TREAT
- Status last verified
- Jan 2020
- First submitted
- 30 Aug 2013
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blaney H, Asgharpour A. The alcohol-associated hepatitis treatment landscape. Curr Opin Gastroenterol. 2026 May 1;42(3):107-113. doi: 10.1097/MOG.0000000000001158. Epub 2026 Feb 13.
PubMed 41691535
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety and Efficacy Study of IMM 124-E (Hyperimmune Bovine Colostrum) for Patients With Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT01968382
- Acronym / sponsor ID
- TREAT / HM20000157
- Conditions
- Hepatitis, Alcoholic
- Keywords
- IMM 124-E, Bovine Colostrum, Alcoholic, Hepatitis, LPS, Hyper-immune
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Immuron Ltd.
- Study start
- Dec 2014
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH).
IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.
Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm 124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on steroids.
Detailed description
Subjects with severe alcoholic hepatitis (20=> MELD <=28) about to receive prednisolone (40 mg/day x 28 days) will be randomized 1:1:1 to additionally receive either one of two doses of IMM 124-E (2400 mg/day or 4800 mg/day) orally or placebo for the same duration. Standard of care nutrition support and alcohol cessation recommendations will be provided to all subjects. Alcohol withdrawal will be managed per standard of care. Subjects who meet Lille criteria for failure of treatment on day 7 or side effects requiring discontinuation of steroids will be removed from the study. The primary endpoint is a decrease in plasma endotoxin levels.
The secondary endpoints will include:
- Mechanistic endpoints: TNF-α, immune-inflammatory markers, microbiome-metagenome
- Efficacy-related: number of subjects meeting Lille failure criteria at day 7 , mortality (at 30 days, 90 days, and 180 days), time to drop in conjugated bilirubin by 50%, bile acids, liver function tests, change in MELD, and sequential organ failure
- Safety related: tolerability, adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMM 124-E 2400 mg/day | Experimental | Drug: IMM 124-E (Hyperimmune Bovine Colostrum), Drug: Placebo (High protein milk powder)Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. |
| IMM 124-E 4800 mg/day | Experimental | Drug: IMM 124-E (Hyperimmune Bovine Colostrum)Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. |
| Placebo (High protein milk powder) | Placebo comparator | Drug: Placebo (High protein milk powder)Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Alcoholic hepatitis
- Men and women age 21 and above
- MELD >= 20 but <=28
- About to initiate prednisolone treatment, < 7 days of steroid treatment, or treatment naive.
- Actively consuming alcohol within 6 weeks of entry into the study
Key exclusion criteria (14 listed)
- Failure to obtain informed consent
- Subjects who are known to be HIV positive
- Active infection or sepsis (pneumonia by X-ray, positive blood or urine culture) or multi-organ failure
- Other or concomitant liver disease present: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
- Cow milk allergy or severe lactose intolerance
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-E (Hyperimmune Bovine Colostrum)Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. | Drug | IMM 124-E 2400 mg/day, IMM 124-E 4800 mg/day |
| Placebo (High protein milk powder)Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily | Drug | IMM 124-E 2400 mg/day, Placebo (High protein milk powder) |
Primary outcome
Gastrointestinal Safety Endpoints
Time frame: 30 Days
Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Combined Kidney, Brain, and Lung Safety Endpoints
Time frame: 30 Days
Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Infection Safety Endpoints
Time frame: 30 Days
Number of incidents of sepsis.
Other Safety Endpoints
Time frame: 30 Days
Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
9 secondary outcomes
Bowel Gastrointestinal Safety Endpoints
Time frame: 30 Days
Change in Circulating Endotoxin Levels
Time frame: Baseline, day 28
Lille Model Score
Time frame: 7 days
Mortality
Time frame: 180 days
Change in Liver Function
Time frame: 90 days
SOFA Score
Time frame: 30 days
Change in Serum Bile Acids
Time frame: Baseline to 90 days
Time to 50% Drop in Bilirubin
Time frame: 180 days
Cytokine Data
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41691535Blaney H, Asgharpour A. The alcohol-associated hepatitis treatment landscape. Curr Opin Gastroenterol. 2026 May 1;42(3):107-113. doi: 10.1097/MOG.0000000000001158. Epub 2026 Feb 13.
Related trials for Hepatitis, Alcoholic
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Hepatitis
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
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.
Arun J Sanyal, MBBS MD principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM 124-E (Hyperimmune Bovine Colostrum) in people with Hepatitis, Alcoholic, run by Virginia Commonwealth University at 3 sites in United States.
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 14 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gastrointestinal Safety Endpoints (time frame: 30 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968382, which also lists 1 linked publication.
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 27 Jan 2020.