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Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis (TREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968382
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Immuron Ltd.
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis, Alcoholic
Interventions Drug: IMM 124-E (Hyperimmune Bovine Colostrum)
Drug: Placebo (High protein milk powder)
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Period Title: Overall Study
Started 18 19 20
Completed 18 19 20
Not Completed 0 0 0
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder) Total
Hide Arm/Group Description

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Total of all reporting groups
Overall Number of Baseline Participants 18 19 20 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 20 participants 57 participants
43.5  (10.2) 44.4  (11) 45.7  (11.8) 44.6  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 20 participants 57 participants
Female
8
  44.4%
10
  52.6%
8
  40.0%
26
  45.6%
Male
10
  55.6%
9
  47.4%
12
  60.0%
31
  54.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 20 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.1%
1
   5.3%
1
   5.0%
4
   7.0%
White
13
  72.2%
18
  94.7%
17
  85.0%
48
  84.2%
More than one race
3
  16.7%
0
   0.0%
0
   0.0%
3
   5.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
  10.0%
2
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 19 participants 20 participants 57 participants
18 19 20 57
1.Primary Outcome
Title Gastrointestinal Safety Endpoints
Hide Description Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Measure Type: Number
Unit of Measure: Incidents
Mild 15 27 7
Moderate 14 25 18
Severe 5 3 6
2.Primary Outcome
Title Combined Kidney, Brain, and Lung Safety Endpoints
Hide Description Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Measure Type: Number
Unit of Measure: incidents
Renal failure 9 10 11
Encephalopathy 0 1 0
Pulmonary compromise 5 6 8
3.Primary Outcome
Title Infection Safety Endpoints
Hide Description Number of incidents of sepsis.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Measure Type: Number
Unit of Measure: Incidents
2 1 2
4.Primary Outcome
Title Other Safety Endpoints
Hide Description Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Measure Type: Number
Unit of Measure: Events
67 113 124
5.Secondary Outcome
Title Bowel Gastrointestinal Safety Endpoints
Hide Description Number of participants who experience diarrhea
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected separately for participants who suffered diarrhea. All gastrointestinal events (including diarrhea) were recorded as generic gastrointestinal events and reported in primary outcome #1.
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Circulating Endotoxin Levels
Hide Description Changes in endotoxin levels as measured using a standard blood assay
Time Frame Baseline, day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
-361.06  (1249.17) -72.94  (755.23) 123.41  (469.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMM 124-E 2400 mg/Day, IMM 124-E 4800 mg/Day, Placebo (High Protein Milk Powder)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3198
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Lille Model Score
Hide Description Number of participants who meet Lille criteria indicating failure to respond to treatment
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 17 19 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  29.4%
6
  31.6%
9
  47.4%
8.Secondary Outcome
Title Mortality
Hide Description Number of deaths due to any cause
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 18 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
5
  27.8%
2
  10.5%
2
  10.0%
9.Secondary Outcome
Title Change in Liver Function
Hide Description Model for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 9 11 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
-8.89  (5.35) -6.82  (4.87) -7.78  (12.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IMM 124-E 2400 mg/Day, IMM 124-E 4800 mg/Day, Placebo (High Protein Milk Powder)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8462
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title SOFA Score
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change in Serum Bile Acids
Hide Description Serum bile acids levels as measured using standard blood serum assay
Time Frame Baseline to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Time to 50% Drop in Bilirubin
Hide Description Length of time to a drop in bilirubin of 50% measured in days
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Cytokine Data
Hide Description Changes in cytokine profile across study arms at day 28
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Hide Arm/Group Description:

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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
Adverse Event Reporting Description An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
 
Arm/Group Title IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
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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 (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

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.

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.

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.

Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

All-Cause Mortality
IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/18 (27.78%)      2/19 (10.53%)      2/20 (10.00%)    
Hide Serious Adverse Events
IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/18 (61.11%)      9/19 (47.37%)      12/20 (60.00%)    
Blood and lymphatic system disorders       
leukocytosis *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders       
abdominal pain *  0/18 (0.00%)  0 1/19 (5.26%)  2 2/20 (10.00%)  5
upper gastrointestinal haemorrhage *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
ascites *  1/18 (5.56%)  2 1/19 (5.26%)  1 1/20 (5.00%)  2
pneumoperitoneum *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
large intestine perforation *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
chronic gastrointestinal bleeding *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
pancreatitis *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
General disorders       
perforated ulcer *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
oedema peripheral *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
multi-organ failure *  1/18 (5.56%)  1 2/19 (10.53%)  2 1/20 (5.00%)  1
systemic inflammatory response syndrome *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
generalised oedema *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Hepatobiliary disorders       
alcoholic liver disease *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
hepatic cirrhosis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
hyperbilirubinaemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
hepatorenal syndrome *  0/18 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
cirrhosis alcoholic *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hepatic function abnormal *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Infections and infestations       
sepsis *  2/18 (11.11%)  2 0/19 (0.00%)  0 2/20 (10.00%)  2
peritonitis bacterial *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
gastrointestinal bacterial infection *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
septic shock *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
pneumonia fungal *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
skin infection *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
abdominal infection *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
idiosyncratic alcohol intoxication *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Investigations       
blood creatinine abnormal *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
blood glucose increased *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders       
hypokalaemia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
lactic acidosis *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
metabolic acidosis *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
hyperglycaemia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hyponatraemia *  1/18 (5.56%)  1 2/19 (10.53%)  3 1/20 (5.00%)  2
hyperkalaemia *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
fluid imbalance *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
dehydration *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hypercalcaemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
musculoskeletal pain *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders       
hepatic encephalopathy *  3/18 (16.67%)  3 1/19 (5.26%)  1 3/20 (15.00%)  4
Encephalopathy *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
headache *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders       
alcohol withdrawal syndrome *  1/18 (5.56%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0
mental status changes *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders       
renal failure acute *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
renal injury *  1/18 (5.56%)  1 2/19 (10.53%)  3 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders       
acute respiratory failure *  2/18 (11.11%)  2 0/19 (0.00%)  0 3/20 (15.00%)  3
dyspnoea *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hypoxia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
pleural effusion *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
lobar pneumonia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hepatic hydrothorax *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
pneumonia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Social circumstances       
alcohol use *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Surgical and medical procedures       
endotracheal intubation *  0/18 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
explorative laparotomy *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
liver transplant *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
alcohol detoxification *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders       
hypotension *  0/18 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMM 124-E 2400 mg/Day IMM 124-E 4800 mg/Day Placebo (High Protein Milk Powder)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/18 (100.00%)      19/19 (100.00%)      17/20 (85.00%)    
Blood and lymphatic system disorders       
leukocytosis *  2/18 (11.11%)  2 3/19 (15.79%)  4 4/20 (20.00%)  4
jaundice *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
coagulopathy *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
anaemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 3/20 (15.00%)  3
pancytopenia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
thrombocytopenia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Cardiac disorders       
sinus tachycardia *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Congenital, familial and genetic disorders       
protein c deficiency *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
hyper IgE syndrome *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Endocrine disorders       
hypothyroidism *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
adrenal insufficiency *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Eye disorders       
vision blurred *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Gastrointestinal disorders       
diarrhoea *  1/18 (5.56%)  1 5/19 (26.32%)  5 1/20 (5.00%)  1
abdominal distension *  0/18 (0.00%)  0 2/19 (10.53%)  2 2/20 (10.00%)  2
abdominal discomfort *  1/18 (5.56%)  1 2/19 (10.53%)  2 0/20 (0.00%)  0
portal hypertensive gastropathy *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
varices oesophageal *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
constipation *  1/18 (5.56%)  1 3/19 (15.79%)  3 0/20 (0.00%)  0
bowel movement irregularity *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
dyspepsia *  1/18 (5.56%)  1 2/19 (10.53%)  3 0/20 (0.00%)  0
flatulence *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
abdominal pain *  3/18 (16.67%)  4 5/19 (26.32%)  7 0/20 (0.00%)  0
ascites *  1/18 (5.56%)  1 2/19 (10.53%)  2 1/20 (5.00%)  2
oral pain *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
parotid gland enlargement *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
nausea *  0/18 (0.00%)  0 3/19 (15.79%)  3 2/20 (10.00%)  2
vomiting *  1/18 (5.56%)  1 3/19 (15.79%)  3 1/20 (5.00%)  2
epigastric discomfort *  2/18 (11.11%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0
pancreatitis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
haematochezia *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
haemorrhoids *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
General disorders       
Oedema *  2/18 (11.11%)  2 1/19 (5.26%)  1 2/20 (10.00%)  2
oedema peripheral *  4/18 (22.22%)  6 5/19 (26.32%)  9 5/20 (25.00%)  6
chills *  0/18 (0.00%)  0 3/19 (15.79%)  4 2/20 (10.00%)  2
fatigue *  2/18 (11.11%)  2 5/19 (26.32%)  5 0/20 (0.00%)  0
hyperthermia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
malaise *  0/18 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
fatigue *  3/18 (16.67%)  3 4/19 (21.05%)  4 1/20 (5.00%)  1
pyrexia *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
Hepatobiliary disorders       
portal hypertension *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
cholecystitis acute *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
intrahepatic portal hepatic venous fistula *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations       
urinary tract infection *  1/18 (5.56%)  1 1/19 (5.26%)  2 1/20 (5.00%)  1
cellulitis *  0/18 (0.00%)  0 2/19 (10.53%)  2 1/20 (5.00%)  1
infective exacerbation of bronchiectasis *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
oral fungal infection *  0/18 (0.00%)  0 1/19 (5.26%)  3 0/20 (0.00%)  0
fungal skin infection *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
oral candidiasis *  0/18 (0.00%)  0 2/19 (10.53%)  2 1/20 (5.00%)  1
tongue abscess *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
gingivitis *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
herpes dermatitis *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
bronchitis *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
brain abscess *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Coxsackie viral infection *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
laceration *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
contusion *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
compression fracture *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
muscle strain *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
excoriation *  0/18 (0.00%)  0 1/19 (5.26%)  1 2/20 (10.00%)  2
skin wound *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
fall *  2/18 (11.11%)  3 0/19 (0.00%)  0 0/20 (0.00%)  0
Investigations       
transaminases increased *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  2
body temperature increased *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
antiphospholipid antibodies positive *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
culture wound positive *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
hyperammonaemia *  3/18 (16.67%)  3 0/19 (0.00%)  0 1/20 (5.00%)  2
blood creatinine increased *  0/18 (0.00%)  0 1/19 (5.26%)  2 2/20 (10.00%)  3
glomerular filtration rate abnormal *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
lipase abnormal *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
blood alkaline phosphatase increased *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  2
blood bilirubin increased *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
urine bilirubin increased *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
weight decreased *  2/18 (11.11%)  2 1/19 (5.26%)  1 0/20 (0.00%)  0
blood lactate dehydrogenase increased *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders       
hypoglycaemia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hypokalaemia *  1/18 (5.56%)  1 3/19 (15.79%)  3 1/20 (5.00%)  1
diabetes mellitus *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
metabolic acidosis *  0/18 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
calciphylaxis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
acidosis * [1]  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
malnutrition *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
hypovitaminosis *  1/18 (5.56%)  1 2/19 (10.53%)  2 0/20 (0.00%)  0
cachexia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  3
hyperkalaemia *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  2
hyponatraemia *  2/18 (11.11%)  2 1/19 (5.26%)  1 2/20 (10.00%)  2
hypoalbuminaemia *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
abnormal weight gain *  3/18 (16.67%)  3 2/19 (10.53%)  2 1/20 (5.00%)  1
polydipsia *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
hypercalcaemia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hypomagnesaemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
hypophosphataemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
hyperglycaemia *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
lactic acidosis *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hyperphosphataemia *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
osteopenia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
myalgia *  0/18 (0.00%)  0 3/19 (15.79%)  3 1/20 (5.00%)  1
muscular weakness *  0/18 (0.00%)  0 3/19 (15.79%)  3 1/20 (5.00%)  1
joint stiffness *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
musculoskeletal pain *  2/18 (11.11%)  2 1/19 (5.26%)  1 1/20 (5.00%)  1
back pain *  1/18 (5.56%)  1 1/19 (5.26%)  1 2/20 (10.00%)  3
arthralgia *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
musculoskeletal chest pain *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders       
dizziness *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
dysgeusia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
tremor *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
asterixis *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  2
hepatic encephalopathy *  1/18 (5.56%)  1 0/19 (0.00%)  0 3/20 (15.00%)  4
peripheral neuropathy *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
presyncope *  0/18 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
lethargy *  0/18 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2
headache *  0/18 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
seizure like phenomena *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
memory impairment *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Psychiatric disorders       
psychogenic seizure *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
mental status changes *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  2
insomnia *  3/18 (16.67%)  3 3/19 (15.79%)  3 0/20 (0.00%)  0
alcohol withdrawal syndrome *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
hallucination, visual *  0/18 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
agitation *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
depression *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
hallucination, auditory *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
suicidal ideation *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
anxiety *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Renal and urinary disorders       
renal injury *  1/18 (5.56%)  1 1/19 (5.26%)  1 5/20 (25.00%)  5
urinary incontinence *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
haematuria *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
renal failure acute *  1/18 (5.56%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0
polyuria *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
oliguria *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
bladder pain *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Reproductive system and breast disorders       
nipple pain *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
amenorrhoea *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
pneumonia *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1
atelectasis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
respiratory disorder *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
epistaxis *  2/18 (11.11%)  3 3/19 (15.79%)  3 0/20 (0.00%)  0
dyspnoea *  1/18 (5.56%)  1 2/19 (10.53%)  2 2/20 (10.00%)  4
pleural effusion *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
cough *  0/18 (0.00%)  0 1/19 (5.26%)  2 2/20 (10.00%)  3
nasal inflammation *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
rash *  0/18 (0.00%)  0 3/19 (15.79%)  5 2/20 (10.00%)  3
acne *  1/18 (5.56%)  1 1/19 (5.26%)  1 1/20 (5.00%)  1
skin necrosis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
pruritus *  3/18 (16.67%)  3 3/19 (15.79%)  3 3/20 (15.00%)  4
blister *  1/18 (5.56%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0
ecchymosis *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  2
skin lesion *  1/18 (5.56%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1
drug reaction with eosinophilia and systemic symptoms *  0/18 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  3
skin striae *  0/18 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0
spider naevus *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
alopecia *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
Surgical and medical procedures       
central venous catheterisation *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
bladder catheterisation *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
debridement *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
lesion excision *  0/18 (0.00%)  0 1/19 (5.26%)  2 0/20 (0.00%)  0
Vascular disorders       
phlebitis *  0/18 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0
hypotension *  0/18 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
mixed respiratory and metabolic
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Taylor MSN, RN
Organization: Virginia Commonwealth University
Phone: 804-828-9311
EMail: stephanie.taylor@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01968382    
Other Study ID Numbers: HM20000157
U01AA021891 ( U.S. NIH Grant/Contract )
IMM-124-E ( Other Identifier: VCU )
First Submitted: August 30, 2013
First Posted: October 24, 2013
Results First Submitted: December 13, 2019
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020