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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
MRG-001
DrugPatients will receive subcutaneous administration of MRG-001 at designated visits.
Treatment groups
32 Participants
are divided into 3 treatment groupsGroup A: MRG-001 (0.005 mL/kg)Experimental treatment 1 intervention
Group B: MRG-001 (0.007 mL/kg)Experimental treatment 1 intervention
Group C: MRG-001 (0.01 mL/kg)Experimental treatment 1 intervention
Trial outcomes
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).
Time frame
28 DaysSecondary outcomes
1
Pharmacokinetic Response
Determine the pharmacokinetics (PK) of MRG-001 in patients with AH. Trough levels (Ctrough) of plerixafor and tacrolimus will be measured throughout the study.
Time frame
28 Days2
Pharmacodynamic Response
The PD response will be measured by flow cytometry. The absolute number of CD34+ hematopoietic stem cells in the peripheral circulation will be assessed and compared to baseline levels.
Time frame
28 DaysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: