Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT01922895
Eligibility Criteria:
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
4. At least 2 of the following symptoms or signs of acute alcoholic hepatitis: Anorexia, nausea, RUQ pain, jaundice, leukocytosis, hepatomegaly AND
5. Elevation of AST \> 80 U/L, but \< 500 U/L at the time of admission or within 3 days of baseline visit; AST \> ALT and ALT \< 200 U/L; total bilirubin \> 3 mg/dL AND
6. 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 the liver biopsy (done within 60 days of inclusion) confirms diagnosis of AAH then inclusion e will be waived.
7. Model for End-Stage Liver Disease (MELD) \<20
8. Willingness to utilize two reliable forms of contraception (both males and females of childbearing potential) from screening through the first six weeks of 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 systemic infection: Fever \> 38o C and positive blood or ascites cultures 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 or history of treatment for tuberculosis; history of any malignancy including hepatocellular carcinoma; known HIV infection
6. Treatment with corticosteroids or other immunosuppressive medications including specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors for \> 3 days within the previous 3 months.
7. Evidence of acute pancreatitis: CT evidence and/or amylase or lipase \> 5 X upper limit of normal
8. Serious cardiac, respiratory or neurologic disease or evidence of autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01922895
Study Brief:
Protocol Section:
NCT01922895