A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 8
- 主要终点
- Survival at 90 Days
研究概览
简要总结
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases.
The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prednisone
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
干预措施: Prednisone (Drug)
Prednisone
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).
干预措施: Placebos (Drug)
Anakinra and Zinc
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
干预措施: Anakinra and Zinc (Drug)
Anakinra and Zinc
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
干预措施: Placebos (Drug)
结局指标
主要结局
Survival at 90 Days
时间窗: 90 days
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
次要结局
- Number of Participants With AKI (Acute Kidney Injury)(7, 30, and 90 days)
- Development of Multi-organ Failure(7, 30, and 90 days)
- Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.(180 days)
- Number of Participants With Infections(180 days)
- Number of Participants With Progression of Sepsis(180 days)
- Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.(180 days)
- Indicators of Gut Permeability(180 days)
- Transplant Free Survival Rate(90 Days)
- Changes in Liver Function(7, 30, and 90 days)
- Percentage of Participants With Renal Dysfunction(180 days)
- To Measure the Changes in Lille Score(Day 7)
- Number of Transfers to ICU(7, 30, and 90 days)
- Changes in MELD Score(7, 30, and 90 days)
- Development of SIRS (Systemic Inflammatory Response Syndrome)(7, 30, and 90 days)
- Survival(30 days and 180 days)
研究者
Samer Gawrieh
Clinical-Director, Alcoholic Hepatitis Network Data Coordinating Center and Associate Professor of Clinical Medicine Division of Gastroenterology and Hepatology
Indiana University