MRG-001 in Patients With Alcoholic Hepatitis

NCT06307522 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: MRG24ALC
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH).

Conditions

Alcoholic Hepatitis; Acute Alcoholic Hepatitis

Keywords

MRG-001; Stem Cells; Immunomodulation; Alcoholic Hepatitis; Hepatitis, Alcoholic; Infection; Liver Diseases, Alcoholic

Outcome Measures

Primary Outcomes (1)

• Assessment of Treatment-Emergent Adverse Events

  Assess the safety and tolerability of MRG-001 in patients with alcoholic hepatitis (AH) as determined by the absence of suspected unexpected serious adverse reaction (SUSAR).

  28 Days

Secondary Outcomes (2)

• Pharmacokinetic Response

  28 Days

• Pharmacodynamic Response

  28 Days

Study Arms (3)

MRG-001 (0.005 mL/kg)

EXPERIMENTAL

Lowest dose of dose-escalation arm

Drug: MRG-001

MRG-001 (0.007 mL/kg)

EXPERIMENTAL

Intermediate dose of dose-escalation arm

Drug: MRG-001

MRG-001 (0.01 mL/kg)

EXPERIMENTAL

High dose of dose-escalation arm

Drug: MRG-001

Interventions

MRG-001 DRUG

Patients will receive subcutaneous administration of MRG-001 at designated visits.

MRG-001 (0.005 mL/kg); MRG-001 (0.007 mL/kg); MRG-001 (0.01 mL/kg)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent: Able to provide written informed consent, either personally or through a legally acceptable representative.
• Male or female patients 21 years of age or older.
• Onset of jaundice within the prior 8 weeks.
• 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.
• 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
• Maddrey Discriminant Function (MDF): MDF ≥ 32, assuming a control prothrombin time of 12 seconds.
• Model for End-stage Liver Disease (MELD) Score: MELD score between 21 and 30.
• 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.
• 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.

You may not qualify if:

• Informed Consent: Inability to provide written informed consent, either personally or through a legally acceptable representative.
• 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.
• 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.
• Liver Biopsy Incompatibility: Liver biopsy findings, if conducted, not compatible with alcoholic hepatitis (AH).
• Absence of Active Infection: No evidence of active infection as determined by the investigator, with specific criteria outlined for diagnosing and treating infections.
• Uncontrolled Gastrointestinal Bleeding: Presence of uncontrolled gastrointestinal bleeding.
• History of pre-admission refractory ascites, as defined by the frequency of paracenteses despite diuretic therapy.
• Significant pre-existing organ dysfunction in various systems, including lung, heart, kidney, hematologic, neurological, and spleen-related conditions.
• Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.
• 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.
• Renal: End-stage renal disease requiring renal replacement therapy or creatintine clearance \<30 mL/min.
• Hematologic: Baseline platelet count \<30,000/mm3 or hemoglobin levels \<6.0 g/dL.
• Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.
• History of splenectomy or splenomegaly (spleen weighing \> 750 g).
• Presence of any active malignancy or malignancy diagnosed within the last five years, excluding curable skin cancer.

Sponsors & Collaborators

• MedRegen LLC: lead

Related Publications (1)

• Ahmadi AR, Atiee G, Chapman B, Reynolds L, Sun J, Cameron AM, Wesson RN, Burdick JF, Sun Z. A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects. Cell Rep Med. 2023 Sep 19;4(9):101169. doi: 10.1016/j.xcrm.2023.101169. Epub 2023 Aug 25.

  PMID: 37633275 RESULT

Related Links

• Company Profile

MeSH Terms

Conditions

Hepatitis, Alcoholic; Infections; Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ali R Ahmadi, MD PhD

  MedRegen LLC

  STUDY DIRECTOR

Central Study Contacts

Ali R Ahmadi, MD PhD

CONTACT

4437598563; info@medregenco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 13, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share