Trial Outcomes & Findings for Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis (NCT NCT04072822)
NCT ID: NCT04072822
Last Updated: 2025-02-10
Results Overview
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
90 days
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Prednisone
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Treatment
STARTED
|
73
|
74
|
|
Treatment
COMPLETED
|
30
|
20
|
|
Treatment
NOT COMPLETED
|
43
|
54
|
|
Follow-up
STARTED
|
30
|
20
|
|
Follow-up
COMPLETED
|
24
|
16
|
|
Follow-up
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Prednisone
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Treatment
Adverse Event
|
9
|
5
|
|
Treatment
Met Stopping Criteria
|
13
|
24
|
|
Treatment
Averse Event and Met Stopping Criteria
|
2
|
9
|
|
Treatment
Withdrawal by Subject
|
0
|
2
|
|
Treatment
Death
|
0
|
2
|
|
Treatment
Lost to Follow-up
|
11
|
3
|
|
Treatment
Physician Decision
|
1
|
0
|
|
Treatment
Other
|
7
|
9
|
|
Follow-up
Withdrawal by Subject
|
1
|
0
|
|
Follow-up
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
Baseline characteristics by cohort
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
Placebos: Matching placebo
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
Placebos: Matching placebo
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
44.7 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
74 participants
n=7 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Survival at 90 Days
|
90 percentage of participants
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: Day 7Population: Participant numbers may vary from participant workflow module due to the data that was able to be collected at sites and timepoints.
Change in Lille score is represented as the percentage of participants who achieved a Lille score \< 0.45 on day 7. The Lille score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis Lille score = (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101\*(age, years) + 0.147\*(albumin day 0, g/L) + 0.0165\* (evolution in bilirubin level, µmol/L) - 0.206\*(renal insufficiency) - 0.0065\*(bilirubin day 0, µmol/L) - 0.0096\*(prothrombin time, sec) Renal insufficiency = 1 (if creatinine \>1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L)) The Lille score was developed to provide early recognition of patients with severe alcoholic hepatitis not responding to corticosteroids. Lower scores indicate more improvement in response to corticosteroids. A Lille score \> 0.45 predicts worse 6-month survival. A Lille score \< 0.45 predicts better 6-month survival.
Outcome measures
| Measure |
Prednisone
n=59 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=61 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
To Measure the Changes in Lille Score
|
67.8 percentage of participants
|
65.6 percentage of participants
|
SECONDARY outcome
Timeframe: 7, 30, and 90 daysPopulation: Participant numbers may vary from participant workflow module due to the data that was able to be collected at sites and timepoints.
The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Outcome measures
| Measure |
Prednisone
n=62 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=63 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Changes in MELD Score
Day 7
|
-2.8 scores on a scale
Standard Deviation 2.9
|
0.2 scores on a scale
Standard Deviation 4.6
|
|
Changes in MELD Score
Day 30
|
-6.9 scores on a scale
Standard Deviation 5.3
|
-1.6 scores on a scale
Standard Deviation 8.3
|
|
Changes in MELD Score
Day 90
|
-10.3 scores on a scale
Standard Deviation 6.1
|
-8.1 scores on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 7, 30, and 90 days* Increase in creatinine of 50% above baseline over a period of 7 days * Increase in creatinine of 0.3 mg/dl within a period of 48 hrs * Onset of renal failure requiring dialysis
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Participants With AKI (Acute Kidney Injury)
Day 90
|
5 Participants
|
5 Participants
|
|
Number of Participants With AKI (Acute Kidney Injury)
Day 7
|
4 Participants
|
17 Participants
|
|
Number of Participants With AKI (Acute Kidney Injury)
Day 30
|
6 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 7, 30, and 90 daysDefined as failure ≥2 organs
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Development of Multi-organ Failure
Day 7
|
3 Number of Subjects
|
2 Number of Subjects
|
|
Development of Multi-organ Failure
Day 30
|
1 Number of Subjects
|
4 Number of Subjects
|
|
Development of Multi-organ Failure
Day 90
|
1 Number of Subjects
|
1 Number of Subjects
|
SECONDARY outcome
Timeframe: 7, 30, and 90 daysDefined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Development of SIRS (Systemic Inflammatory Response Syndrome)
Day 7
|
0 Events
|
2 Events
|
|
Development of SIRS (Systemic Inflammatory Response Syndrome)
Day 30
|
2 Events
|
0 Events
|
|
Development of SIRS (Systemic Inflammatory Response Syndrome)
Day 90
|
1 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 7, 30, and 90 daysRecording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Transfers to ICU
Day 90
|
2 Transfers
|
0 Transfers
|
|
Number of Transfers to ICU
Day 7
|
2 Transfers
|
5 Transfers
|
|
Number of Transfers to ICU
Day 30
|
2 Transfers
|
9 Transfers
|
SECONDARY outcome
Timeframe: 7, 30, and 90 daysPopulation: Due to lab issues and participant follow-up at certain sites, numbers analyzed differ from lab test to timepoint
Changes in liver function were evaluated by changes in the Child Pugh Score at days 7, 30, and 90. The Child Pugh Score is a scoring system used to assess the severity of chronic liver disease. Scores range from 5 to 15, with higher scores indicating more severe disease. Points are assigned as follows: Hepatic encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, mild = 2 points, moderate to severe = 3 points Total Bilirubin: under 2 mg/dl = 1 point, 2 to 3 mg/dl = 2 points, over 3 mg/dl = 3 points Albumin: greater than 3.5g/dl = 1 point, 2.8 to 3.5g/dl = 2 points, less than 2.8g/dl = 3 points International normalised ratio (INR): under 1.7 = 1 point, 1.7 to 2.3 = 2 points, above 2.3 = 3 points Assigned points for each category are summed to calculate the Child Pugh Score.
Outcome measures
| Measure |
Prednisone
n=72 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=72 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Changes in Liver Function
Day 0
|
10.3 score on a scale
Standard Deviation 1.7
|
10.1 score on a scale
Standard Deviation 1.4
|
|
Changes in Liver Function
Day 7
|
9.4 score on a scale
Standard Deviation 1.5
|
9.7 score on a scale
Standard Deviation 1.6
|
|
Changes in Liver Function
Day 30
|
8.5 score on a scale
Standard Deviation 2.0
|
9.2 score on a scale
Standard Deviation 2.0
|
|
Changes in Liver Function
Day 90
|
7.2 score on a scale
Standard Deviation 2.0
|
8.0 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 180 daysThe SOFA score will be calculated at the following website https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score Scores can be from 0 - \>14 (favorable to less favorable)
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
Increase in SOFA > 2 points
|
3 Participants
|
3 Participants
|
|
Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
Need for hemodynamic support
|
9 Participants
|
11 Participants
|
|
Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
Renal replacement therapy
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Participants With Infections
|
20 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 180 days* Life-threatening organ dysfunction caused by a dysregulated host response to infection * An increase in SOFA score of 2 points of more * Note: most participants with severe AH have 4 points based on bilirubin only
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Participants With Progression of Sepsis
Sepsis
|
3 Participants
|
0 Participants
|
|
Number of Participants With Progression of Sepsis
Sepsis shock
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 180 daysDefined by a creatinine \> 2 mg/dl
Outcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Percentage of Participants With Renal Dysfunction
|
21.9 Percentage of Participants
|
47.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.
|
6 Participant counts
|
15 Participant counts
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Zero participants analyzed, data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days and 180 daysOutcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Survival
Day 30
|
97 Percentage of Participants
|
85 Percentage of Participants
|
|
Survival
Day 180
|
81 Percentage of Participants
|
68 Percentage of Participants
|
SECONDARY outcome
Timeframe: 90 DaysOutcome measures
| Measure |
Prednisone
n=73 Participants
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 Participants
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Transplant Free Survival Rate
|
88 Percentage of Participants
|
64 Percentage of Participants
|
Adverse Events
Prednisone
Serious events: 41 serious events
Other events: 45 other events
Deaths: 12 deaths
Anakinra and Zinc
Serious events: 49 serious events
Other events: 51 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Prednisone
n=73 participants at risk
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 participants at risk
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
4/73 • Number of events 4 • 6 months
|
5.4%
4/74 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain generalized
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Abdominal wall hematoma
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Acute anemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
17.8%
13/73 • Number of events 15 • 6 months
|
40.5%
30/74 • Number of events 36 • 6 months
|
|
Blood and lymphatic system disorders
Acute post hemorrhagic anemia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.1%
3/73 • Number of events 4 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
Alcohol intoxication
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Alcoholic hepatitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Injury, poisoning and procedural complications
Alcoholic withdrawal symptoms
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Anasarca
|
5.5%
4/73 • Number of events 5 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Ascites
|
2.7%
2/73 • Number of events 2 • 6 months
|
6.8%
5/74 • Number of events 5 • 6 months
|
|
Nervous system disorders
Ataxia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Bacteremia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Bleeding tendencies
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Blood in stool
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
C.difficile colitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
COVID-19 pneumonia
|
4.1%
3/73 • Number of events 3 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Cardiogenic pulmonary edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Infections and infestations
Central line infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Chronic pancreatitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Confusion
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Death
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Vascular disorders
Deep vein thrombosis leg
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Depression
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Injury, poisoning and procedural complications
Detoxification
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Empyema
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Encephalopathy
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Encephalopathy hepatic
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Encephalopathy toxic acute
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Epistaxis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Esophageal varices hemorrhage
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Evacuation of subdural hematoma
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Fall
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Fever
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Fluid overload
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
GI bleed
|
4.1%
3/73 • Number of events 4 • 6 months
|
6.8%
5/74 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhagic
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Generalized edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Hematemesis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Hematochezia
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Hematoma muscle
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Hemoperitoneum
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Hemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
1.4%
1/73 • Number of events 1 • 6 months
|
6.8%
5/74 • Number of events 5 • 6 months
|
|
General disorders
Hospice care
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Endocrine disorders
Hyperglycemia
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Hypokalemia
|
0.00%
0/73 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Hyponatremia
|
4.1%
3/73 • Number of events 5 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Cardiac disorders
Hypotension
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypotonic dehydration
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
2.7%
2/73 • Number of events 3 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Ileus of colon
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased shortness of breath
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 2 • 6 months
|
|
Vascular disorders
Internal bleeding
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Liver function test increased
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Liver transplant
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Macrocytic anemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Metabolic acidosis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Multi-organ failure
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Perineal abscess
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
4.1%
3/73 • Number of events 4 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
RUQ pain
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Refractory shock
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Vascular disorders
Retroperitoneal hemorrhage
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
SIRS
|
2.7%
2/73 • Number of events 3 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
STEMI
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Septic arthritis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Septic shock
|
2.7%
2/73 • Number of events 2 • 6 months
|
6.8%
5/74 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
Serum creatinine increased
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Shock
|
0.00%
0/73 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Cardiac disorders
Shock circulatory
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Nervous system disorders
Subdural hematoma
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Substance-induced mood disorder
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/73 • Number of events 2 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Infections and infestations
Varicella zoster virus infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
Other adverse events
| Measure |
Prednisone
n=73 participants at risk
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.
Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
|
Anakinra and Zinc
n=74 participants at risk
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Number of events 2 • 6 months
|
5.4%
4/74 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Abnormal chest sounds
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Accidental overdose (therapeutic agent)
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Nervous system disorders
Acute confusional state
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
3/73 • Number of events 3 • 6 months
|
10.8%
8/74 • Number of events 9 • 6 months
|
|
Nervous system disorders
Agitation
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Injury, poisoning and procedural complications
Alcohol intoxication acute
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Alcoholic cirrhosis of liver
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Immune system disorders
Allergy
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Anasarca
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Ankle edema
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Ankle swelling
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Anxiety
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Ascites
|
6.8%
5/73 • Number of events 5 • 6 months
|
8.1%
6/74 • Number of events 19 • 6 months
|
|
Hepatobiliary disorders
Ascites grade 2
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Infections and infestations
Bacteremia
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Breath sounds
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
COVID-19 pneumonia
|
2.7%
2/73 • Number of events 2 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Central line infection
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Chest pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Confusion
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/73 • Number of events 2 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/73 • Number of events 2 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough nonproductive
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Crackles lung
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Vascular disorders
Dehydration
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
2/73 • Number of events 2 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Nervous system disorders
Dizziness
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Dysuria
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Metabolism and nutrition disorders
Ecchymosis injection site
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Edema
|
2.7%
2/73 • Number of events 2 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Edema dependent
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Edema limbs
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Edema lower limb
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Edema of legs
|
2.7%
2/73 • Number of events 4 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Cardiac disorders
Edema of lower extremities
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Edema pulmonary
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Elevated liver enzyme levels
|
4.1%
3/73 • Number of events 3 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Encephalopathy
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Hepatobiliary disorders
Encephalopathy acute
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Encephalopathy hepatic
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Epigastric pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Esophageal varices without mention of bleeding
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Fall
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
General disorders
Fatigue
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
General disorders
Fever
|
2.7%
2/73 • Number of events 2 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
1.4%
1/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Gas pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Gastrocnemius equinus
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Endocrine disorders
Glucose abnormal
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Hallucinations
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Hematochezia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Hematoma
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/73 • 6 months
|
4.1%
3/74 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Hepatosplenomegaly
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Endocrine disorders
Hyperglycemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 3 • 6 months
|
|
Endocrine disorders
Hyperglycemia drug-induced
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Hypokalemia
|
9.6%
7/73 • Number of events 8 • 6 months
|
9.5%
7/74 • Number of events 7 • 6 months
|
|
Renal and urinary disorders
Hypomagnesaemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Hyponatremia
|
2.7%
2/73 • Number of events 3 • 6 months
|
5.4%
4/74 • Number of events 4 • 6 months
|
|
Renal and urinary disorders
Hypophosphatemia
|
2.7%
2/73 • Number of events 2 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
INR increased
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Immune system disorders
Infusion reaction
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Immune system disorders
Injection site reaction
|
4.1%
3/73 • Number of events 3 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Nervous system disorders
Insomnia
|
12.3%
9/73 • Number of events 9 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.5%
4/73 • Number of events 4 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Klebsiella pneumoniae pneumonia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Left upper quadrant pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.0%
8/73 • Number of events 9 • 6 months
|
5.4%
4/74 • Number of events 4 • 6 months
|
|
Reproductive system and breast disorders
Libido decreased
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Liver scan NOS abnormal
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Cardiac disorders
Lower leg edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Blood and lymphatic system disorders
Macrocytic anemia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Mental status changes
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle injury
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscular back pain
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
9.6%
7/73 • Number of events 7 • 6 months
|
9.5%
7/74 • Number of events 7 • 6 months
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
1.4%
1/73 • Number of events 1 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Nervous system disorders
Neuropathy
|
4.1%
3/73 • Number of events 3 • 6 months
|
0.00%
0/74 • 6 months
|
|
Injury, poisoning and procedural complications
Nicotine craving
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Night sweats
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Paracentesis
|
1.4%
1/73 • Number of events 2 • 6 months
|
4.1%
3/74 • Number of events 4 • 6 months
|
|
Surgical and medical procedures
Paracentesis abdominis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pedal edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Cardiac disorders
Peripheral edema
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
Portal hypertension
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/73 • Number of events 1 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash (nonspecific)
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Nervous system disorders
Restless legs
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Serum creatinine increased
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shallow breathing
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Sore throat
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Skin and subcutaneous tissue disorders
Spider angioma
|
2.7%
2/73 • Number of events 2 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Cardiac disorders
Tachycardia
|
4.1%
3/73 • Number of events 3 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
General disorders
Temperature elevation
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.1%
3/73 • Number of events 3 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Vascular disorders
Thrombophlebitis arm superficial
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Tibia fracture
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Transjugular intrahepatic portosystemic shunt
|
1.4%
1/73 • Number of events 1 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Nervous system disorders
Unsteady gait
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Urgency urination
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/73 • 6 months
|
4.1%
3/74 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Vasopressin decreased urine output
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/73 • 6 months
|
2.7%
2/74 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
WBC decreased
|
0.00%
0/73 • 6 months
|
1.4%
1/74 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
WBC increased
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
|
General disorders
Weakness
|
1.4%
1/73 • Number of events 1 • 6 months
|
0.00%
0/74 • 6 months
|
Additional Information
Samer Gawrieh, MD
Indiana University School of Medicine
Phone: (317) 278-9326
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place