Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

Sponsor
Mack Mitchell (Other)
Overall Status
Completed
CT.gov ID
NCT01809132
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), The Cleveland Clinic (Other), University of Massachusetts, Worcester (Other), University of Louisville (Other)
104
4
3
61
26
0.4

Study Details

Study Description

Brief Summary

This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6 months and the two treatment groups will be compared for differences in death rates and laboratory tests that measure liver and gut function.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

This study will test the hypothesis that the syndrome of acute alcoholic hepatitis results from severe inflammation and dysregulated cytokines. Steroid monotherapy is not effective in all patients and this study will utilize compounds that have the potential to improve gut barrier function, to reduce the associated inflammation, and to prevent the development of hepatorenal syndrome and other organ failure.

Patients will be randomized to receive 28 days of methylprednisolone 32 mg daily OR therapy that includes a combination of anakinra (interleukin-1 receptor antagonist) 100mg by subcutaneous injection daily for 14 days plus pentoxifylline 400 mg orally three times daily for one month plus zinc supplements (220 mg of zinc sulfate) given orally for 6 months. This combination strategy will address the acute inflammatory component of the disease (anakinra) and protect against development of hepatorenal syndrome (pentoxifylline), one of the most frequent causes of death in severe acute alcoholic hepatitis, and improve gut mucosal integrity (zinc supplements). The primary outcome will be 6 month mortality rate. Secondary outcomes will be measured at 30, 90 and 180 days.

Individuals who are not participating in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anakinra & Pentoxifylline & Zinc Sulfate

anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days

Drug: Anakinra
Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.
Other Names:
  • Kineret
  • Drug: Pentoxifylline
    Pentoxifylline, generic
    Other Names:
  • Pentoxifylline, generic
  • Drug: Zinc Sulfate
    Zinc Sulfate, nutritional supplement
    Other Names:
  • Zinc Sulfate, generic
  • Active Comparator: Methylprednisolone

    methylprednisolone 32 mg orally daily for 28 days

    Drug: Methylprednisolone
    Methylprednisolone, corticosteroid
    Other Names:
  • Methylprednisolone, generic
  • No Intervention: Observational

    Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.

    Outcome Measures

    Primary Outcome Measures

    1. 180 Days Mortality [Time to event up to 6 months]

      Death at 180 days

    Secondary Outcome Measures

    1. MELD Score at 28 Days [28 days]

      Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.

    2. MELD Score at 90 Days [90 Days]

      Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.

    3. MELD Score at 180 Days [180 Days]

      Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Ability to provide informed consent by subject or appropriate family member

    2. Age between 21-70 years

    3. Recent alcohol consumption > 50 g/d for > 6 months, continuing within two months before enrollment

      1. At least 2 of the following symptoms of acute alcoholic hepatitis: Anorexia, nausea, RUQ pain
    4. Liver biopsy showing alcoholic hepatitis (steatohepatitis) OR ultrasound of liver showing increased echogenicity OR CT scan showing decreased attenuation of liver compared to spleen OR MRI showing fatty liver (decreased signaling intensity on T1 weighted images) If liver biopsy confirms diagnosis of alcoholic hepatitis then requirement for AST elevation > 50 is waived. The liver biopsy must be done within 60 days of study enrollment.

    5. AST levels:

    • AST> Or equal to 50 IU/mL but less than 500 IU/mL

    • AST> ALT, ratio AST/ALT> 1.5; ALT < 200 IU/mL

    • or biopsy proven alcoholic hepatitis.

    1. Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32.

    2. Willingness to utilize two reliable forms of contraception (both males and females of childbearing potential) from screening through the first 6 weeks of the study.

    Exclusion Criteria:
    1. Hypotension with BP < 80/50 after volume repletion

    2. Pregnancy; incarceration; inability to provide consent or lack of appropriate family member

    3. Signs of uncontrolled systemic infection: Fever > 38°C and positive blood or ascites cultures and on appropriate antibiotic therapy for ≥ 3 days within 3 days of inclusion

    4. Acute gastrointestinal bleeding requiring >2 units blood transfusion within the previous 4 days

    5. Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test, a positive quantiferon, or history of treatment for tuberculosis; history of any malignancy except skin cancer but including hepatocellular carcinoma within the last five years; HIV infection

    6. Recent previous treatment with corticosteroids or other immunosuppressive medications including specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors within the previous 3 months. Treatment with corticosteroids for ≤3 days prior to baseline is acceptable.

    7. Evidence of acute pancreatitis: CT evidence or amylase or lipase > 5 X upper limit of normal (ULN).

    8. Serious cardiac, respiratory or neurologic disease or evidence of other liver diseases such as autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, secondary iron overload due to chronic hemolysis, alpha-1-antitrypsin deficiency

    9. Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Louisville Louisville Kentucky United States 40202
    2 University of Massachusetts Medical School Worcester Massachusetts United States 01655
    3 Cleveland Clinic Cleveland Ohio United States 44195
    4 University of Texas Southwestern Medical Center Dallas Texas United States 75390-9030

    Sponsors and Collaborators

    • Mack Mitchell
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    • The Cleveland Clinic
    • University of Massachusetts, Worcester
    • University of Louisville

    Investigators

    • Principal Investigator: Mack C Mitchell, MD, University of Texas Southwestern Medical Center
    • Principal Investigator: Arthur J McCullough, MD, The Cleveland Clinic
    • Principal Investigator: Craig J McClain, MD, University of Louisville
    • Principal Investigator: Gyongi Szabo, MD, University of Massachusetts, Worcester

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mack Mitchell, Professor of Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01809132
    Other Study ID Numbers:
    • U01AA021893-01
    • U01AA021893-01
    First Posted:
    Mar 12, 2013
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    Period Title: Overall Study
    STARTED 53 50 1
    COMPLETED 53 50 0
    NOT COMPLETED 0 0 1

    Baseline Characteristics

    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational Total
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected. Total of all reporting groups
    Overall Participants 53 50 1 104
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    53
    100%
    50
    100%
    0
    0%
    103
    99%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    18
    34%
    22
    44%
    1
    100%
    41
    39.4%
    Male
    35
    66%
    28
    56%
    0
    0%
    63
    60.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    10
    18.9%
    9
    18%
    0
    0%
    19
    18.3%
    Not Hispanic or Latino
    38
    71.7%
    38
    76%
    1
    100%
    77
    74%
    Unknown or Not Reported
    5
    9.4%
    3
    6%
    0
    0%
    8
    7.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    1.9%
    0
    0%
    0
    0%
    1
    1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    9.4%
    3
    6%
    0
    0%
    8
    7.7%
    White
    47
    88.7%
    47
    94%
    1
    100%
    95
    91.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title 180 Days Mortality
    Description Death at 180 days
    Time Frame Time to event up to 6 months

    Outcome Measure Data

    Analysis Population Description
    Intention to treat
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    Measure Participants 53 50 0
    Count of Participants [Participants]
    17
    32.1%
    22
    44%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anakinra & Pentoxifylline & Zinc Sulfate, Methylprednisolone
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .30
    Comments
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title MELD Score at 28 Days
    Description Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.
    Time Frame 28 days

    Outcome Measure Data

    Analysis Population Description
    This outcome could not be calculated for the observational subject who was lost to follow up. Analysis were limited to the subjects that were alive for this time point.
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    Measure Participants 30 29 0
    Mean (Standard Deviation) [score on a scale]
    22.57
    (6.31)
    20.95
    (6.44)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anakinra & Pentoxifylline & Zinc Sulfate, Methylprednisolone
    Comments the observational subject was lost to follow-up
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .42
    Comments
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title MELD Score at 90 Days
    Description Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.
    Time Frame 90 Days

    Outcome Measure Data

    Analysis Population Description
    This outcome could not be calculated for the observational subject who was lost to follow up. Analysis were limited to the subjects that were alive for this time point.
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    Measure Participants 22 17 0
    Mean (Standard Deviation) [score on a scale]
    15.50
    (6.11)
    16.38
    (9.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anakinra & Pentoxifylline & Zinc Sulfate, Methylprednisolone
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .75
    Comments
    Method t-test, 2 sided
    Comments
    4. Secondary Outcome
    Title MELD Score at 180 Days
    Description Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.
    Time Frame 180 Days

    Outcome Measure Data

    Analysis Population Description
    This outcome could not be calculated for the observational subject who was lost to follow up. Analysis were limited to the subjects that were alive for this time point.
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will be receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    Measure Participants 19 15 0
    Mean (Standard Deviation) [score on a scale]
    15.81
    (10.10)
    11.85
    (4.47)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anakinra & Pentoxifylline & Zinc Sulfate, Methylprednisolone
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .17
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description The definitions of adverse events are the same as those used in clinicaltrials.gov Adverse events were not collected for the observational arm.
    Arm/Group Title Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Arm/Group Description anakinra 100mg subcutaneous injection daily for 14 days pentoxifylline 400 mg orally three times daily for 28 day zinc sulfate 220 mg orally for 180 days Anakinra: Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection. Pentoxifylline: Pentoxifylline, generic Zinc Sulfate: Zinc Sulfate, nutritional supplement methylprednisolone 32 mg orally daily for 28 days Methylprednisolone: Methylprednisolone, corticosteroid Individuals who choose not to participate in the interventional arm of the trial will receive standard care and be observed for 6 months. They will be enrolled to have baseline and interval health information and laboratory results collected.
    All Cause Mortality
    Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 17/53 (32.1%) 22/50 (44%) 0/0 (NaN)
    Serious Adverse Events
    Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 33/53 (62.3%) 30/50 (60%) 0/0 (NaN)
    Cardiac disorders
    Ascites 6/53 (11.3%) 6 0/50 (0%) 0 0/0 (NaN) 0
    Cardiac failure 0/53 (0%) 0 1/50 (2%) 1 0/0 (NaN) 0
    Tachycardia 2/53 (3.8%) 2 0/50 (0%) 0 0/0 (NaN) 0
    General disorders
    Multiple Organ Dysfunction Syndrome (MODS) 2/53 (3.8%) 2 3/50 (6%) 3 0/0 (NaN) 0
    Hepatobiliary disorders
    Hepatic failure 3/53 (5.7%) 3 0/50 (0%) 0 0/0 (NaN) 0
    Esophageal varices hemorrhage 2/53 (3.8%) 2 1/50 (2%) 1 0/0 (NaN) 0
    Infections and infestations
    Clostridium difficile infection 4/53 (7.5%) 4 2/50 (4%) 2 0/0 (NaN) 0
    Aspergillus infection 0/53 (0%) 0 3/50 (6%) 3 0/0 (NaN) 0
    Nocardia sepsis 0/53 (0%) 0 1/50 (2%) 1 0/0 (NaN) 0
    Histoplasmosis infection 0/53 (0%) 0 1/50 (2%) 1 0/0 (NaN) 0
    Baceteremia 1/53 (1.9%) 1 1/50 (2%) 1 0/0 (NaN) 0
    Candida infection 0/53 (0%) 0 1/50 (2%) 1 0/0 (NaN) 0
    Peritonitis 2/53 (3.8%) 2 0/50 (0%) 0 0/0 (NaN) 0
    Viremia 1/53 (1.9%) 1 0/50 (0%) 0 0/0 (NaN) 0
    Nervous system disorders
    Encephalopathy 3/53 (5.7%) 3 2/50 (4%) 2 0/0 (NaN) 0
    Renal and urinary disorders
    Acute Kidney Injury 10/53 (18.9%) 10 13/50 (26%) 13 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome 0/53 (0%) 0 2/50 (4%) 2 0/0 (NaN) 0
    Respiratory Failure 2/53 (3.8%) 2 3/50 (6%) 3 0/0 (NaN) 0
    Hypoxia 0/53 (0%) 0 2/50 (4%) 2 0/0 (NaN) 0
    Pneumonia 0/53 (0%) 0 2/50 (4%) 2 0/0 (NaN) 0
    Lung infection 0/53 (0%) 0 2/50 (4%) 2 0/0 (NaN) 0
    Vascular disorders
    Upper GI hemorrhage 4/53 (7.5%) 4 4/50 (8%) 4 0/0 (NaN) 0
    Other (Not Including Serious) Adverse Events
    Anakinra & Pentoxifylline & Zinc Sulfate Methylprednisolone Observational
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 20/53 (37.7%) 4/50 (8%) 0/0 (NaN)
    Gastrointestinal disorders
    Nausea 5/53 (9.4%) 5 0/50 (0%) 0 0/0 (NaN) 0
    Hepatobiliary disorders
    Ascites 3/53 (5.7%) 3 3/50 (6%) 3 0/0 (NaN) 0
    Infections and infestations
    C. difficile infection 3/53 (5.7%) 3 1/50 (2%) 1 0/0 (NaN) 0
    Renal and urinary disorders
    Urinary tract infection 5/53 (9.4%) 5 0/50 (0%) 0 0/0 (NaN) 0
    Vascular disorders
    Hematemesis 4/53 (7.5%) 4 0/50 (0%) 0 0/0 (NaN) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Mack C. Mitchell
    Organization UTexas Southwestern Medical Center
    Phone 2146485036
    Email mack.mitchell@utsouthwestern.edu
    Responsible Party:
    Mack Mitchell, Professor of Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01809132
    Other Study ID Numbers:
    • U01AA021893-01
    • U01AA021893-01
    First Posted:
    Mar 12, 2013
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021