ID

12562

Description

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT01809132

Link

https://clinicaltrials.gov/show/NCT01809132

Keywords

Versions (1)
  1. 11/30/15 11/30/15 -
Uploaded on

November 30, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Alcoholic Hepatitis NCT01809132

English

Eligibility Acute Alcoholic Hepatitis NCT01809132

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to provide informed consent by subject or appropriate family member
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age between 21-70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. recent alcohol consumption > 50 g/d for > 6 months, continuing within two months before enrollment
Description

alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
at least 2 of the following symptoms of acute alcoholic hepatitis: anorexia, nausea, right upper quadrant pain, jaundice, leukocytosis, hepatomegaly and
Description

symptoms of acute alcoholic hepatitis:

Data type

boolean

Alias
UMLS CUI [1]
C0001306
5. elevation of ast > 80 u/l within 3 days of baseline, but < 500 u/l; ast > alt and alt < 200 u/l; total bilirubin > 3 mg/dl.
Description

elevation of ast > 80 u/l within 3 days of baseline, but < 500 u/l; ast > alt and alt < 200 u/l; total bilirubin > 3 mg/dl.

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205161
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 > 80 is waived. the liver biopsy must be done within 60 days of study enrollment.
Description

liver biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0412534
UMLS CUI [3]
C0412621
UMLS CUI [4]
C2718067
model for end-stage liver disease (meld) ≥ 20 and maddrey df ≥ 32.
Description

model for end-stage liver disease (meld)

Data type

boolean

Alias
UMLS CUI [1]
C3826979
willingness to utilize two reliable forms of contraception from screening through the first 6 weeks of the study.
Description

(both males and females of childbearing potential)

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypotension with bp < 80/50 after volume repletion
Description

hypotension

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0020649
pregnancy; incarceration; inability to provide consent or lack of appropriate family member
Description

pregnancy; incarceration; inability to provide consent or lack of appropriate family member

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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
Description

uncontrolled systemic infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C3646020
acute gastrointestinal bleeding requiring >2 units blood transfusion within the previous 4 days
Description

acute gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0266807
UMLS CUI [2]
C0005841
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
Description

undue risk from immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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.
Description

recent previous treatment with corticosteroids or other immunosuppressive medications

Data type

boolean

Alias
UMLS CUI [1]
C2347852
7. evidence of acute pancreatitis: ct evidence or amylase or lipase > 5 x upper limit of normal (uln).
Description

acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0001339
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
Description

serious cardiac, respiratory or neurologic disease or evidence of other liver diseases

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
9. acute or chronic kidney injury with serum creatinine > 3.0 mg/dl.
Description

kidney injury

Data type

boolean

Alias
UMLS CUI [1]
C2609414
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Similar models

Eligibility Acute Alcoholic Hepatitis NCT01809132

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
ability to provide informed consent by subject or appropriate family member
boolean
C0021430 (UMLS CUI [1])
Age
Item
age between 21-70 years
boolean
C0001779 (UMLS CUI [1])
alcohol consumption
Item
3. recent alcohol consumption > 50 g/d for > 6 months, continuing within two months before enrollment
boolean
C0001948 (UMLS CUI [1])
symptoms of acute alcoholic hepatitis:
Item
at least 2 of the following symptoms of acute alcoholic hepatitis: anorexia, nausea, right upper quadrant pain, jaundice, leukocytosis, hepatomegaly and
boolean
C0001306 (UMLS CUI [1])
elevation of ast > 80 u/l within 3 days of baseline, but < 500 u/l; ast > alt and alt < 200 u/l; total bilirubin > 3 mg/dl.
Item
5. elevation of ast > 80 u/l within 3 days of baseline, but < 500 u/l; ast > alt and alt < 200 u/l; total bilirubin > 3 mg/dl.
boolean
C1254595 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
liver biopsy
Item
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 > 80 is waived. the liver biopsy must be done within 60 days of study enrollment.
boolean
C0193388 (UMLS CUI [1])
C0412534 (UMLS CUI [2])
C0412621 (UMLS CUI [3])
C2718067 (UMLS CUI [4])
model for end-stage liver disease (meld)
Item
model for end-stage liver disease (meld) ≥ 20 and maddrey df ≥ 32.
boolean
C3826979 (UMLS CUI [1])
willingness to utilize two reliable forms of contraception
Item
willingness to utilize two reliable forms of contraception from screening through the first 6 weeks of the study.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypotension
Item
hypotension with bp < 80/50 after volume repletion
boolean
C0009488 (UMLS CUI [1,1])
C0020649 (UMLS CUI [1,2])
pregnancy; incarceration; inability to provide consent or lack of appropriate family member
Item
pregnancy; incarceration; inability to provide consent or lack of appropriate family member
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
uncontrolled systemic infection
Item
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
boolean
C0009488 (UMLS CUI [1])
C3646020 (UMLS CUI [2])
acute gastrointestinal bleeding
Item
acute gastrointestinal bleeding requiring >2 units blood transfusion within the previous 4 days
boolean
C0266807 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
undue risk from immunosuppression
Item
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
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
recent previous treatment with corticosteroids or other immunosuppressive medications
Item
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.
boolean
C2347852 (UMLS CUI [1])
acute pancreatitis
Item
7. evidence of acute pancreatitis: ct evidence or amylase or lipase > 5 x upper limit of normal (uln).
boolean
C0001339 (UMLS CUI [1])
serious cardiac, respiratory or neurologic disease or evidence of other liver diseases
Item
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
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
kidney injury
Item
9. acute or chronic kidney injury with serum creatinine > 3.0 mg/dl.
boolean
C2609414 (UMLS CUI [1])
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