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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03432260
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide written informed consent (either from patient or patient's legally acceptable representative)
2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
3. Patients with alcoholic hepatitis defined as:
1. History of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, AND
2. Consumed alcohol within 12 weeks of entry into the study, AND
3. Serum bilirubin \> 3 mg/dL AND AST \> ALT, but less than 300 U/L AND
4. MELD score between 11-30, inclusive
4. No evidence of active infection as determined by the investigator.
5. Women of child-bearing potential must utilize appropriate birth control throughout the study duration.
6. Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration
Exclusion Criteria:
1. Other or concomitant cause(s) of liver disease as a result of:
1. Autoimmune liver disease
2. Wilson disease
3. Vascular liver disease
4. Drug induced liver disease
2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
3. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
4. If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding
5. Serum creatinine \> 2.5 mg/dL
6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
7. Stage 3 or greater encephalopathy by West Haven criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03432260
Study Brief:
Protocol Section:
NCT03432260