Clinical trial NCT01968382
Conditions: Hepatitis, Alcoholic
Keywords: IMM 124-E Bovine Colostrum Alcoholic Hepatitis LPS Hyper-immune
Sponsor: Virginia Commonwealth University
Start date: 2014-12-01; Completion date: 2018-12-22
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

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:

1. Mechanistic endpoints: TNF-α, immune-inflammatory markers, microbiome-metagenome
2. 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
3. Safety related: tolerability, adverse events.

Arms: arm 1: 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. arm 2: 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. arm 3: 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.
Interventions: intervention 1: IMM 124-E (Hyperimmune Bovine Colostrum) intervention 2: Placebo (High protein milk powder)
Intervention descriptions: intervention 1: Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. intervention 2: Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Protocol documents:
Prot_SAP_000.pdf: 
 
 
Title: A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety, and Efficary Study of 
IMM 124-E (Hyperimmune Bovine Colostrum) for Patients with Severe Alcoholic Hepatitis. 
 
NCT #: NCT01968382 
 
Document approval date: August 15, 2016 
 
Document Type: Full study protocol and statistical analysis plan 
 
 
 





















































































































ICF_001.pdf: 
 
 
Title: A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety, and Efficary Study of 
IMM 124-E (Hyperimmune Bovine Colostrum) for Patients with Severe Alcoholic Hepatitis. 
 
NCT #: NCT01968382 
 
Document approval date: August 10, 2017 
 
Document Type: Informed Consent 
 
 
 


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RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM
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
VCU IRB PROTOCOL NUMBER: HM20000157
INVESTIGATOR:  Arun J. Sanyal MD
Virginia Commonwealth University
Suthat Liangpunsakul MD
Indiana University
Vijay Shah MD
Mayo Clinic Rochester
SPONSOR:
National Institute on Alcohol Abuse and Alcoholism
Secondary Sponsor: Immuron Ltd. 
19 Kavanaugh Street
Southbank, VIC 3006, Australia
If any information contained in this consent form is not clear, please ask the study doctor 
or the study staff to explain any information that you do not fully understand.  You will 
be provided an unsigned copy of this consent form to think about or discuss with family 
or friends before making your decision.  
In this consent form, “you” always refers to the research participant.  If you are a legally 
authorized representative, please remember that “you” refers to the study participant.
PURPOSE OF THE STUDY
The purpose of this research study is to test the safety, tolerability, and effectiveness of 
Imm 124-E (Bovine Colostrum Drug Substance or BCDS) when used to treat severe 
alcoholic hepatitis.  You are being asked to participate in this study because you have 
been diagnosed with severe alcoholic hepatitis and may meet the study entry 
requirements.
Alcoholic hepatitis causes jaundice (yellowing of the skin and eyes), right sided upper 
abdominal pain, enlarged liver, and fever.  The way that alcoholic hepatitis develops is 
not completely understood.  It is believed that a chemical called lipopolysaccharide (LPS) 
which is produced by the body is the driving force behind this illness.  Imm 124-E acts by 
binding LPS in your intestinal tract, thus lowering the levels of this chemical in the body.    
Drugs called steroids are the current treatment for alcoholic hepatitis.  You will be 
prescribed these steroid drugs by your doctor since this is the established way that this 
illness is treated and we do not know yet if Imm124-E will be effective. 
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DESCRIPTION OF THE STUDY 
Imm124-E is an investigational drug, which means it has not been approved by the U. S. 
Food and Drug Administration (FDA).  We have permission from the FDA to use this 
drug for this clinical trial. In this study, we will compare two different doses of Imm124-
E to placebo (a look-alike inactive substance). 
Your participation in this study will last up to six months. Two other universities are 
involved in this study:  Indiana University, Indianapolis, and Mayo Clinic, Rochester.    
A total of 66 individuals will participate in this study here and at the other two sites. 
If significant new findings develop during the course of the research which may relate to 
your willingness to continue participation, this information will be provided to you.
PROCEDURES
If you decide to be in this research study, you will be asked to sign this consent form after 
you have had all your questions answered. 
At your first study visit (Visit 1), your medical history will be taken, a physical exam will 
be performed, and a record of medications that you are taking will be made. The physical 
exam will include measurements of your height, weight and vital signs (pulse, blood 
pressure and temperature). Measurements of your waist, hips, and arm will be done as 
part of an overall nutrition assessment.  Blood samples will be collected for routine lab 
tests.  Approximately 3 tablespoons of blood will be collected.  Women of childbearing 
potential will have a pregnancy test done. We will ask you to complete questionnaires 
about your alcohol use, your quality of life, your sleep habits, and tobacco and marijuana 
use. 
Research study samples will be collected at this visit.  These include a stool sample and 
urine sample; two tablespoons of blood will be drawn for research purposes.   
If you meet entry criteria and still agree to participate, you will start study medication in 
addition to the steroid medication that you are already taking.  Abstinence from alcohol 
should be maintained during your participation in the study and is essential in the 
prevention of the progression of your liver disease.
You will be randomly assigned (like the flip of a coin) to receive either:

Imm124-E 2400 mg a day 

Imm124-E 4800 mg a day 

Placebo 
The study drug will be taken as a powder, mixed with four tablespoons of water in a cup, 
with two packets of the study drug provided, twice a day.  The study drug will need to be 
mixed gently in a cup and then you will drink the entire contents.  Additional water may 
be added to the cup to ensure all the powder has been taken.
You have one chance in three of being assigned to placebo, and two chances in three            
of receiving either Imm124-E 2400 mg a day or 4800 mg a day.  You will take the study 
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drug for 4 weeks (28 days).  You will be instructed on when and how to take the study 
drug.  You will be instructed not to discard any study drug or any empty packets but to 
return all to the study coordinator at your study visits. 
Neither you nor the study doctor will know which study drug you are receiving.  This 
information is available to the study doctor if needed in an emergency. This is done 
(blinding) so that a fair evaluation of results may be made.
Visit 2 will take place 7 days after Visit 1. You may still be in the hospital at the time of 
this visit.  If you have been discharged, you will be scheduled to see the doctor and the 
study coordinator on the Clinical Research Services Unit (CRSU).  Research samples 
consisting of about two tablespoons of blood will be drawn at this visit in addition to any 
routine labs ordered for your care.  Urine and stool samples will also be collected.  The 
doctors will evaluate your medical condition at this visit by using your lab results to 
determine if you are responding to treatment. If you are not responding, then the drug 
may be discontinued. You will have a physical exam, weight and vital signs, a 
medication review, and if you are a woman of childbearing potential, another urine 
pregnancy test will be done.  
Visit 3 will be scheduled 28 -30 days after Visit 1.  You will be asked about your health 
since the last visit and you will have a physical exam, weight, and vital signs. Research 
samples and routine labs will be collected as they were during your first visit.  These 
include taking about two tablespoons of blood for research samples and about 3 
tablespoons for standard lab work, and collecting urine and stool samples. If you are still 
on study drug, it will be discontinued at this visit.  You should bring all of your 
remaining study drug supply to the research clinic. This includes any empty drug packets 
that you may have. We will review your other medications with you and make a record of 
these also. If you are a woman of childbearing potential, another urine pregnancy test will 
be done. 
Visit 4 will take place about 90 days after Visit 1.  Your medications will be reviewed as 
well as any changes in your health since your last visit.  You will have a physical exam 
which will include weight, and vital signs. Routine standard of care lab work will be 
done.  If you are a woman of childbearing potential, another urine pregnancy test will be 
done. 
Visit 5, the last visit for this clinical trial, will be scheduled 180 days (about 6 months) 
after Visit I and will include a physical exam, weight, vital signs, and hip and waist, and 
arm measurements. Routine labs will be drawn as part of your regular care.  Research 
samples will be collected.  This includes about 2 tablespoons of blood, a urine sample, 
and a stool sample. You will be asked about your health since your last visit and a record 
will be made of your current medications. We will ask you to complete questionnaires 
about your alcohol use, your quality of life, your sleep habits, and tobacco and marijuana 
use.  These are the same questionnaires that you completed at Visit 1. 
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The doctor may ask you to come in for a clinic visit anytime during the 180 study days if 
he thinks that you need a closer follow up for your care.  You may request an extra 
appointment at any time that you feel you need to be seen by the doctor. 
Liver biopsies will not be performed specifically for this research study.   However, if 
you have had a liver biopsy, we will use that data as part of this study.  Should you have a 
liver biopsy in the future, we will request that a small piece of the biopsy sample, if it is 
available, be used for research purposes. Only extra available liver tissue will be used so 
there is no increased risk to you during this procedure or in making a correct diagnosis of 
your liver disease. We will explain that to you more if and when you do have a liver 
biopsy.  
You may be asked to participate in another study after you have completed this one.  
Would you like to be contacted for that study?   
Yes     No
______________________
Initial
RISKS AND DISCOMFORTS
Imm124-E is marketed in Australia under the brand name “Travelan”.  It is used for 
traveler’s diarrhea.  One hundred forty thousand packets (30 tablets per packet) have been 
sold over the counter to adults and children over age 6.  No adverse effects have been 
reported by the Australian regulatory board.  
Possible side effects associated with the use of Imm124-E include:

Nausea and vomiting

Abdominal pain

Diarrhea

Intestinal gas/bloating
Allergic reaction to Imm124- E is possible.  Severe allergic reactions can be life 
threatening.  There may be other unknown effects from Imm124-E, but the likelihood is 
low.  
Your condition may not get better or may become worse while you are in the study. 
As the study procedures might injure an unborn child, pregnant women may not 
participate. Women who might become pregnant should use a medically accepted form of 
birth control such as total abstinence, birth control pills, an IUD, diaphragm, progesterone 
injections or implants, or condoms plus a spermicide. Methods of birth control other than 
total abstinence are not 100% effective, and should a women become pregnant there may 
be risk of injury to an unborn child.  For similar reasons, women who are nursing an 
infant may not participate.
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For men, the study procedures might increase the risks for birth defects of any child 
conceived during treatment and several months after treatment is stopped. Men in this 
study who have the potential of fathering children should be aware of this possibility and 
consider using a medically accepted form of birth control.  
Only the study participant can take the study drug.  It must be kept out of the reach of 
children and persons who may not be able to read or understand the label.
The following risks may be associated with the study:

Blood draw:  the risks of the blood draw include slight pain, bruising, fainting, 
and rarely, infection.  Trained people will perform the blood collection

Questionnaires: One of the risks associated with answering questions is loss of 
confidentiality. Every effort will be made to keep personal information 
confidential. You will be assigned a study code so that it is unlikely to trace back 
to who you are based on your background/questionnaire information.  You might 
also feel uncomfortable answering some of the questions.  You do not have to 
answer any questions that you are not comfortable answering. 

Physical examination:  There is no significant risk associated with physical 
examination. 
USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION
Authority to Request Protected Health Information
The following people and/or groups may request my Protected Health Information:

Principal Investigator and Research Staff    

Study Sponsor (NIAAA)    

Research Investigators at other sites 
involved in this study

Institutional Review Boards   

Data Safety Monitoring Boards   

Food and Drug Administration

 Department of Health and Human Services 
Authority to Release Protected Health Information 
The VCU Health System (VCUHS) may release the information identified in this 
authorization from my medical records and provide this information to:  

Health Care Providers at the VCUHS   

Principal Investigator and Research Staff     

Study Sponsor (NIAAA)

Food and Drug Administration  
Research Investigators at other sites 
involved in this study    

Data Coordinators  

Institutional Review Boards     

Data Safety Monitoring Boards     

Department of Health and Human Services   
Once your health information has been disclosed to anyone outside of this study, the 
information may no longer be protected under this authorization. An example of this is if 
you request your information such as test results be released to your primary care 
physician, then this authorization does not assure their confidentiality. 
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Type of Information that may be Released 
The following types of information may be used for the conduct of this research:
 Complete health record
 Diagnosis & treatment 
codes
 Discharge summary
 History and physical exam
 Consultation reports
 Progress notes
 Laboratory test results
 X-ray reports
 X-ray films / images
 Photographs, videotapes
Complete billing record
 Itemized bill
 Information about drug or alcohol abuse
 Information about Hepatitis B or C tests
 Information about psychiatric care
 Information about sexually transmitted 
diseases
 Other (specify):       
Expiration of this Authorization  
 This authorization will expire when the research study is closed, or there is no need to 
review, analyze and consider the data generated by the research project, whichever is 
later.
 This research study involves the use of a Data or Tissue Repository (bank) and will 
never expire.
  Other (specify):       
Right to Revoke Authorization and Re-disclosure
You may change your mind and revoke (take back) the right to use your protected health 
information at any time.  Even if you revoke this Authorization, the researchers may still 
use or disclose health information they have already collected about you for this study. If 
you revoke this Authorization you may no longer be allowed to participate in the research 
study.  To revoke this Authorization, you must write to the Principal Investigator.
BENEFITS TO YOU AND OTHERS
During this study, you will receive steroid medications which is the current treatment for 
alcoholic hepatitis.  IMM 124-E may be beneficial to you in addition to the use of steroid 
drugs.  However, this benefit cannot be guaranteed.  It is not known if IMM 124-E will 
be harmful but it is unlikely.  You will be carefully monitored while taking this 
medication and it can be discontinued at any time during the 28 days that you will receive 
it.  
COSTS
Study drug will be provided by the sponsor.  There are no charges for clinic visits related 
to this study. Samples drawn for research study purposes will be covered.  Any tests, 
which include laboratory tests done as part of your routine medical care, will not be 
covered by this study.  This will be billed to your insurance.  If your insurance does not 
pay, then you will be responsible for the cost.  Having a liver biopsy is not part of this 
study so should you undergo a liver biopsy, it will be billed to your insurance company. 
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ALTERNATIVE TREATMENT
You do not have to participate in this study to receive treatment for alcoholic hepatitis 
because you will be treated with steroid medications which is the standard treatment.  In 
this study, you will be receiving study drug or placebo in addition to the steroid 
medications if you choose to participate. The study doctor will discuss this with you.  
Your disease is directly caused by excessive alcohol consumption.  Abstinence is 
essential in the prevention of the progression of your liver disease.  
CONFIDENTIALITY 
As with all research, there is a chance that confidentiality could be compromised; 
however, we take precautions to minimize the risk. Potentially identifiable information 
about you will consist of blood samples, urine samples, stool samples, questionnaires, 
and data extracted from your medical records.  Data are being collected only for research 
purposes.  Study records that identify you will be kept confidential. You will not be 
identified by name, social security number, address, telephone number, or any other 
direct personal identifier in study records disclosed outside this institution. You 
understand that the results of the research study may be published in medical journals, 
but that your name or identity will not be revealed and that your record will remain 
confidential. A study code number will be used to keep track of your files in an 
anonymous manner. All personal identifying information will be kept in password 
protected files and these files will be stored for 15 years, or until after the study is 
complete, whichever is longer.  Other records such as doctors’ notes, lab results, and x-
ray reports will be stored indefinitely.   Access to all data will be limited to study 
personnel.  
As part of this study, your doctor and the study staff will ask you to have certain tests.  
Some of these blood and urine tests would have been done as part of your regular care.  
They will use these test results to both treat you and to complete this research.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. law.  This website will not include information that can identify you.  At 
most, the website will include a summary of the results.  You can search this website at 
any time. 
DATA REGISTRIES
Your doctor will collect several samples of bio-specimens (consisting of blood, urine, and 
stool samples) from you during this study.  The test results from these samples are for 
research purposes only.  The testing is being conducted for exploratory research purposes 
only and has no clear implications about you or your family medical conditions.
Some of your samples will be stored at Indiana Biobank, a Specimen Storage Facility, 
supported by the National Institutes of Health.  The purpose of this collection is to have 
samples available for use in research and clinical factors related to your disease even after 
the current study is completed.  Storing samples may provide researchers with valuable 
material that can help them to develop new diagnostic tests, new treatments, and new 
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ways to prevent disease.  All specimens will be labeled with an identification number and 
the date your sample was collected.  Your name will not be on any blood, urine, and stool 
samples and the “key” which links your identity to your samples will be stored separately 
and securely at VCU.  Your blood sample will be stored for as long as possible and will 
be used in future testing.  The research studies in which the specimens may be used have 
not yet been fully determined.
If you decide at any time during the research study that you would like to withdraw your 
samples from the study, you will need to put your request in writing to the study doctor or 
study team.  Your samples will be removed from the Indiana Biobank.  You will receive 
written notification when this has been done. 
Other researchers at VCU who aren’t involved with this study may ask to use your 
sample for future research.  Researchers at other institutions may also ask for a part of 
your sample for future studies.  Your samples will be sent to researchers in a coded 
format, which protects your identity.  
1. I give permission for my data/tissue samples collected at VCU Medical Center to 
be stored at the Indiana Biobank and used for future research related to liver 
disease or research on any major disease, health condition or risk factor.
YES  
NO   ____________________       
___________________
Initial
Date
2.  I give permission to VCU Medical Center to give my samples which have been 
collected at VCU Medical Center and stored at the Indiana Biobank to other 
researchers at other institutions to be stored and used in future research related to 
liver disease or research on any major disease, health condition, or risk factor. 
YES   
NO     ____________________
___________________
Initial
Date
COMPENSATION FOR INJURY or ILLNESS 
If you are injured by, or become ill, from participating in this study, please contact your 
study doctor immediately.  Medical treatment is available at the Virginia Commonwealth 
University Health System (VCU Health System).  Your study doctor will arrange for 
short-term emergency care at the VCU Health System or for a referral if it is needed.  
Fees for such treatment may be billed to you or to appropriate third party insurance.  
Your health insurance company may or may not pay for treatment of injuries or illness as 
a result of your participation in this study.  
To help avoid research-related injury or illness it is very important to follow all study 
directions.
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VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary.  You may decide to not participate in this 
study.  Your decision not to take part will involve no penalty or loss of benefits to which 
you are otherwise entitled.  If you do participate, you may freely withdraw from the study 
at any time.  Your decision to withdraw will involve no penalty or loss of benefits to 
which you are otherwise entitled.
Your participation in this study may be stopped at any time by the study doctor or the 
sponsor without your consent. The reasons might include:
 the study doctor thinks it necessary for your health or safety;
 you have not followed study instructions;
 the sponsor has stopped the study; or
 administrative reasons require your withdrawal.
If you leave the study before the final regularly scheduled visit, we may ask you to come 
in to see the doctor and study coordinator for an early close out visit. 
If you decide to stop participating in this study, your samples will no longer be provided 
to researchers and no more data will be collected.  However, any research already 
conducted on your samples and information collected will remain part of the research 
project using them unless you wish to request in writing that your samples and data be 
destroyed.  You can provide a written request to any investigator in this study.  
QUESTIONS
If you have any questions, complaints, or concerns about your participation in this 
research, contact:
Dr. Arun Sanyal 
     and/or
Dr. Velimir Luketic,  Dr. M. Shadab Siddiqui
 At 804-828-4060, 24 hours 7days/week.  
Or you may contact your study coordinator at the same number.  
You may write to your study doctor at the following address:
Dr. Arun Sanyal
VCU Medical Center
1200 East Broad Street
Room 1490
Box 980341
Richmond, VA 23298
The researcher/study staff named above is the best person(s) to call for questions about 
your participation in this study. 
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If you have general questions about your rights as a participant in this or any other 
research, you may contact:
Office of Research
Virginia Commonwealth University
800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number for general questions, concerns, or complaints about research. You 
may also call this number if you cannot reach the research team or if you wish to talk to 
someone else. General information about participation in research studies can also be 
found at http://www.research.vcu.edu/irb/volunteers.htm
Do not sign this consent form unless you have had a chance to ask questions and have 
received satisfactory answers to all of your questions.  
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CONSENT 
I have been provided with an opportunity to read this consent form carefully.  All of the 
questions that I wish to raise concerning this study have been answered.  
By signing this consent form, I have not waived any of the legal rights or benefits, to 
which I otherwise would be entitled.  My signature indicates that I freely consent to 
participate in this research study.  I will receive a copy of the consent form once I have 
agreed to participate.
________________________________________________
Participant Name, printed
________________________________________________ ________________
Participant Signature 
Date
___________________________________                ____________________________
Name of Legally Authorized Representative                Relationship to Participant
(Printed)
_______________________________________________ ________________
Legally Authorized Representative Signature
Date
________________________________________________
Name of Person Conducting Informed Consent 
Discussion / Witness 
(Printed)
________________________________________________ ________________
Signature of Person Conducting Informed Consent
Date
Discussion / Witness 
________________________________________________ ________________ 
Investigator Signature (if different from above) 
Date 
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