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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT02971306
Eligibility Criteria:
Inclusion Criteria:
Alcoholic hepatitis patients:
1. More than 10 years of heavy alcohol consumption (mean intake ≈ 100 g/day).
2. Elevated aspartate aminotransferase level (but \<500 IU per millilitre) and Ratio ofAST/ALT≥2 times
3. Elevated serum total bilirubin level ≥ 5 mgdL (86 μmol/L)
4. Elevated INR(≥1.5) and
5. Neutrophilia. Patient with Maddrey's DF of≥ 32 will be included in the study, with or without biopsy.
Exclusion Criteria:
1. Age \< 18 and \> 75 years
2. Hepatocellular carcinoma or portal vein thrombosis
3. Refusal to participate in the study
4. Serum creatinine \>1.0 mg%
5. Hepatic encephalopathy- grade 3 or 4
6. Upper gastrointestinal bleed in last ten days
7. Uncontrolled bacterial infection
8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency
9. Pregnancy
10. Glucocorticoid treatment
11. Significant co-morbidity
12. Previous known hypersensitivity to G-CSF/NAC
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02971306
Study Brief:
Protocol Section:
NCT02971306