Not Yet RecruitingPhase 2

MRG-001 in Patients With Alcoholic Hepatitis

32 participantsStarted 2024-09-01

Plain-language 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).

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Assessment of Treatment-Emergent Adverse Events

Timeframe: 28 Days

Trial details

NCT IDNCT06307522

SponsorMedRegen LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Ali R Ahmadi, MD PhD

4437598563 info@medregenco.com

View on ClinicalTrials.gov More Alcoholic Hepatitis trials