NCT06307522尚未招募2 期
An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- MedRegen LLC
- 入组人数
- 32
- 主要终点
- Assessment of Treatment-Emergent Adverse Events
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
- •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-
- •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.
研究组 & 干预措施
MRG-001 (0.005 mL/kg)
Experimental
Lowest dose of dose-escalation arm
干预措施: MRG-001 (Drug)
MRG-001 (0.007 mL/kg)
Experimental
Intermediate dose of dose-escalation arm
干预措施: MRG-001 (Drug)
MRG-001 (0.01 mL/kg)
Experimental
High dose of dose-escalation arm
干预措施: MRG-001 (Drug)
结局指标
主要结局
Assessment of Treatment-Emergent Adverse Events
时间窗: 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).
次要结局
- Pharmacokinetic Response(28 Days)
- Pharmacodynamic Response(28 Days)
研究者
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