MRG-001 in Patients With Alcoholic Hepatitis

Launched by MEDREGEN LLC · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of an experimental medication called MRG-001 for patients with severe alcoholic hepatitis, a serious liver condition caused by heavy drinking. The researchers want to find out how different doses of the medication affect the body and whether it can help improve the condition. The trial is not yet recruiting participants, but it will be open to men and women aged 21 and older who have experienced jaundice (a yellowing of the skin and eyes) within the last eight weeks and have a history of significant alcohol consumption.

To qualify for the study, potential participants should be able to give informed consent and meet specific health criteria related to their liver function. Participants can expect to undergo assessments to ensure they meet these criteria and may need to use contraception during the study if they are of childbearing age. It's important to note that individuals with certain other health issues or who are currently taking part in other clinical trials may not be eligible. Overall, this trial aims to find new ways to help those suffering from alcoholic hepatitis and improve their health outcomes.

Gender

ALL

Eligibility criteria

• 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.