MRG-001 in Patients With Alcoholic Hepatitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedRegen LLC
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- MRG-001
Treatment groups
32 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov