Randomized Placebo Controlled Pilot Trial to determine the efficacy of an IL22 agonist (F-652) in patients with Alcoholic Hepatitis

随机安慰剂对照预试验以确定 IL22 激动剂 (F-652) 对酒精性肝炎患者的疗效

基本信息

  • 批准号:
    10202402
  • 负责人:
  • 金额:
    $ 7.5万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2018
  • 资助国家:
    美国
  • 起止时间:
    2018-09-22 至 2023-06-30
  • 项目状态:
    已结题

项目摘要

PROJECT SUMMARY/ABSTRACT Alcoholic hepatitis (AH) is a leading cause of liver-related morbidity and mortality with a remarkable paucity of effective therapeutics. F-652, an IL-22 agonist, is a promising agent to treat patients with AH because of its antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and pro-proliferative effects that have been demonstrated in various experimental systems. A pilot study from our group in patients with AH has confirmed safety and suggested efficacy of F-652, with no worrisome pharmacodynamic or pharmacokinetic patterns. Based on the encouraging results from the pilot study, this application represents the next step to confirm efficacy of the IL-22 agonist in patients with AH. The aims of this proposal are: 1. Determine the efficacy and confirm the safety of an IL-22 agonist (F-652) in a randomized, placebo-controlled study in patients with AH and MELD score 11-20 as demonstrated by improved MELD scores at 90 days. Patients with AH and MELD score 11-20 (thus not candidates for the trial described in our linked application to RFA-AA-18-002) will undergo a 1:1 randomization into an IL-22 agonist arm or a placebo (control) arm. Three doses of the IL-22 agonist or placebo will be administered at approximately 5-day intervals. The primary endpoint is improvement (reduction) in MELD score by >25% at 90 days. Secondary endpoints include 30- and 90-day survival; Lille score; and safety as determined by absence of serious adverse events (SAE) at 90 days. 2. Determine the efficacy and confirm the safety of an IL-22 agonist (F-652) in a randomized, placebo-controlled study in patients with AH and MELD score 21-28 as demonstrated by improved MELD scores at 90 days. Patients with AH with contraindication to steroids (thus not candidates for the trial described in our linked application to RFA-AA 18-002) and MELD score 21-28 will undergo a 2:1 randomization into an IL-22 agonist arm or a placebo (control) arm. Three doses of the IL-22 agonist or placebo will be administered at approximately 5-day intervals. Secondary endpoints include 30- and 90-day survival; Lille score; and safety as determined by absence of SAE up to 90 days. We believe a pilot randomized controlled trial is a logical extension of our preliminary studies which demonstrated safety and possible efficacy of the IL-22 agonist in patients with AH. The investigators are uniquely positioned to perform the proposed study given substantial breadth and depth of expertise related to AH, clinical trial conduct, and therapeutic development.
项目总结/文摘

项目成果

期刊论文数量(0)
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VIJAY H. SHAH其他文献

VIJAY H. SHAH的其他文献

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{{ truncateString('VIJAY H. SHAH', 18)}}的其他基金

Molecular Mechanisms of Liver Fibrosis
肝纤维化的分子机制
  • 批准号:
    10407227
  • 财政年份:
    2022
  • 资助金额:
    $ 7.5万
  • 项目类别:
Molecular Mechanisms of Liver Fibrosis
肝纤维化的分子机制
  • 批准号:
    10612941
  • 财政年份:
    2022
  • 资助金额:
    $ 7.5万
  • 项目类别:
Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic
肝硬化网络:临床研究中心 - 梅奥诊所
  • 批准号:
    10487453
  • 财政年份:
    2021
  • 资助金额:
    $ 7.5万
  • 项目类别:
Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic
肝硬化网络:临床研究中心 - 梅奥诊所
  • 批准号:
    10310667
  • 财政年份:
    2021
  • 资助金额:
    $ 7.5万
  • 项目类别:
Liver Cirrhosis Network: Clinical Research Center - Mayo Clinic
肝硬化网络:临床研究中心 - 梅奥诊所
  • 批准号:
    10700154
  • 财政年份:
    2021
  • 资助金额:
    $ 7.5万
  • 项目类别:
Assessment of Alcoholic Hepatitis with Multiparametric Magnetic Resonance Elastography
多参数磁共振弹性成像评估酒精性肝炎
  • 批准号:
    10459414
  • 财政年份:
    2018
  • 资助金额:
    $ 7.5万
  • 项目类别:
Assessment of Alcoholic Hepatitis with Multiparametric Magnetic Resonance Elastography
多参数磁共振弹性成像评估酒精性肝炎
  • 批准号:
    10205237
  • 财政年份:
    2018
  • 资助金额:
    $ 7.5万
  • 项目类别:
Randomized Placebo Controlled Pilot Trial to determine the efficacy of an IL22 agonist (F-652) in patients with Alcoholic Hepatitis
随机安慰剂对照预试验以确定 IL22 激动剂 (F-652) 对酒精性肝炎患者的疗效
  • 批准号:
    9791141
  • 财政年份:
    2018
  • 资助金额:
    $ 7.5万
  • 项目类别:
Randomized Placebo Controlled Pilot Trial to determine the efficacy of an IL22 agonist (F-652) in patients with Alcoholic Hepatitis
随机安慰剂对照预试验以确定 IL22 激动剂 (F-652) 对酒精性肝炎患者的疗效
  • 批准号:
    10449219
  • 财政年份:
    2018
  • 资助金额:
    $ 7.5万
  • 项目类别:
Assessment of Alcoholic Hepatitis with Multiparametric Magnetic Resonance Elastography
多参数磁共振弹性成像评估酒精性肝炎
  • 批准号:
    9791139
  • 财政年份:
    2018
  • 资助金额:
    $ 7.5万
  • 项目类别:

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