Alcoholic HepatitisPhase 2NCT06307522
MRG-001 in Patients With Alcoholic Hepatitis
A Phase 2 study testing MRG-001 in people with Alcoholic Hepatitis and Acute Alcoholic Hepatitis, run by MedRegen LLC.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Hepatitis, Acute Alcoholic Hepatitis
- What is being tested?
- MRG-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Patients requiring the use of vasopressors or inotropic support, excluding stabilized conditions within the first 7 days of hospital admission.
- Presence of co-infection with human immunodeficiency virus (HIV) or active tuberculosis on chest X-ray at study entry.
- History of organ or bone marrow transplantation, excluding corneal transplant, or recent chronic use of immunosuppressive drugs.
- Positive urine drug screen for specific substances, excluding THC and prescription medications.
- Hypersensitivity to either of the components of MRG-001.
- If female, known pregnancy, positive serum pregnancy test, or lactating/breastfeeding.
- Underlying diseases that might be complicated or exacerbated by proposed treatments or confound assessment of study drug, as determined by the site investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis
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
- Being tested
- MRG-001
- Keywords
- MRG-001, Stem Cells, Immunomodulation, Alcoholic Hepatitis, Hepatitis, Alcoholic, Infection, Liver Diseases, Alcoholic
- Medical subject headings
- Hepatitis, Alcoholic, Infections, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-001Drug
Patients will receive subcutaneous administration of MRG-001 at designated visits.
| Study group | Role | What they receive |
|---|---|---|
| MRG-001 (0.005 mL/kg) | Experimental | Lowest dose of dose-escalation arm Receives: Drug: MRG-001 |
| MRG-001 (0.007 mL/kg) | Experimental | Intermediate dose of dose-escalation arm Receives: Drug: MRG-001 |
| MRG-001 (0.01 mL/kg) | Experimental | High dose of dose-escalation arm Receives: Drug: MRG-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 Days
Secondary outcomes (2)
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.
Measured: 28 Days
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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedRegen LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali R Ahmadi, MD PhD, Study director, MedRegen LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307522
- Sponsor's protocol ID
- MRG24ALC
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37633275
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT06307522
- Acronym / sponsor ID
- MRG24ALC
- Conditions
- Alcoholic Hepatitis, Acute Alcoholic Hepatitis
- Keywords
- MRG-001, Stem Cells, Immunomodulation, Alcoholic Hepatitis, Hepatitis, Alcoholic, Infection, Liver Diseases, Alcoholic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- MedRegen LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRG-001 (0.005 mL/kg) | Experimental | Drug: MRG-001Lowest dose of dose-escalation arm |
| MRG-001 (0.007 mL/kg) | Experimental | Drug: MRG-001Intermediate dose of dose-escalation arm |
| MRG-001 (0.01 mL/kg) | Experimental | Drug: MRG-001High dose of dose-escalation arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG-001Patients will receive subcutaneous administration of MRG-001 at designated visits. | Drug | MRG-001 (0.005 mL/kg), MRG-001 (0.007 mL/kg), MRG-001 (0.01 mL/kg) |
Primary outcome
Assessment of Treatment-Emergent Adverse Events
Time frame: 28 Days
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).
2 secondary outcomes
Pharmacokinetic Response
Time frame: 28 Days
Pharmacodynamic Response
Time frame: 28 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 37633275Ahmadi 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.
- Company ProfileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali R Ahmadi, MD PhD study director
MedRegen LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG-001 in people with Alcoholic Hepatitis and Acute Alcoholic Hepatitis, run by MedRegen LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali R Ahmadi, MD PhD (4437598563, info@medregenco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Treatment-Emergent Adverse Events (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.