| Eligibility |
Inclusion Criteria:
1. Informed Consent: Able to provide written informed consent, either personally or
through a legally acceptable representative.
2. Male or female patients 21 years of age or older.
3. Onset of jaundice within the prior 8 weeks.
4. Alcohol Consumption: Average daily consumption of more than 40 grams for females or
more than 60 grams for males of alcohol for 6 months or longer, with less than 8 weeks
of abstinence before the onset of jaundice.
5. Diagnostic Criteria for AH: AH may be diagnosed based on typical serum chemistry or
liver biopsy during the current episode of AH, including:
- Serum bilirubin > 3 mg/dL
- AST between 50 and 400 IU/L
- ALT < 400 IU/L
- AST/ALT ratio > 1.5
6. Maddrey Discriminant Function (MDF): MDF = 32, assuming a control prothrombin time of
12 seconds.
7. Model for End-stage Liver Disease (MELD) Score: MELD score between 21 and 30.
8. Liver Biopsy (Optional): Liver biopsy is not required but may be used to confirm the
diagnosis of AH at the Investigator's discretion. If used, the biopsy must have
occurred during the current episode.
9. Contraception for Women: Women of childbearing potential must use appropriate birth
control throughout the study duration. Contraception for Men: Male patients must agree
to use a medically acceptable method of contraception or birth control throughout the
study duration.
Exclusion Criteria:
1. Informed Consent: Inability to provide written informed consent, either personally or
through a legally acceptable representative.
2. Participation in Other Clinical Trials: Participation in another interventional
clinical trial (drug or device) within 30 days of screening and at any time during the
study.
3. Concomitant Liver Diseases: Presence of other concomitant causes of liver disease,
such as viral hepatitis, autoimmune liver disease, metabolic liver disease, or
vascular liver disease.
4. Liver Biopsy Incompatibility: Liver biopsy findings, if conducted, not compatible with
alcoholic hepatitis (AH).
5. Absence of Active Infection: No evidence of active infection as determined by the
investigator, with specific criteria outlined for diagnosing and treating infections.
6. Uncontrolled Gastrointestinal Bleeding: Presence of uncontrolled gastrointestinal
bleeding.
7. History of pre-admission refractory ascites, as defined by the frequency of
paracenteses despite diuretic therapy.
8. Significant pre-existing organ dysfunction in various systems, including lung, heart,
kidney, hematologic, neurological, and spleen-related conditions.
1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing
medical condition (other than COVID-19), as documented in medical record.
2. Heart: Pre-existing congestive heart failure defined as an ejection fraction <20%
as documented in the medical record. Clinically significant ventricular
arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina,
myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3
months), significant valvular heart disease, uncontrolled arterial hypertension
with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
3. Renal: End-stage renal disease requiring renal replacement therapy or creatintine
clearance <30 mL/min.
4. Hematologic: Baseline platelet count <30,000/mm3 or hemoglobin levels <6.0 g/dL.
5. Neurological: Stage =3 hepatic encephalopathy by West Haven criteria.
6. History of splenectomy or splenomegaly (spleen weighing > 750 g).
9. Presence of any active malignancy or malignancy diagnosed within the last five years,
excluding curable skin cancer.
10. Patients requiring the use of vasopressors or inotropic support, excluding stabilized
conditions within the first 7 days of hospital admission.
11. Presence of co-infection with human immunodeficiency virus (HIV) or active
tuberculosis on chest X-ray at study entry.
12. History of organ or bone marrow transplantation, excluding corneal transplant, or
recent chronic use of immunosuppressive drugs.
13. Positive urine drug screen for specific substances, excluding THC and prescription
medications.
14. Hypersensitivity to either of the components of MRG-001.
15. If female, known pregnancy, positive serum pregnancy test, or lactating/breastfeeding.
16. Underlying diseases that might be complicated or exacerbated by proposed treatments or
confound assessment of study drug, as determined by the site investigator.
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