Pilot Trial UO1 DUR-928
试点试验 UO1 DUR-928
基本信息
- 批准号:10201423
- 负责人:
- 金额:$ 6.94万
- 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:2018-09-25 至 2023-06-30
- 项目状态:已结题
- 来源:
- 关键词:25-hydroxycholesterolADD-1 proteinAcuteAcute Alcoholic HepatitisAcute Renal Failure with Renal Papillary NecrosisAdrenal Cortex HormonesAgonistAlcohol abuseAlcoholic HepatitisAlcoholic Liver DiseasesAlcoholic beverage heavy drinkerAlcoholsAnorexiaApoptosisBiologyCell NucleusCell SurvivalCholesterolCholesterol HomeostasisChronicClinical DataCytoplasmDataDevelopmentDietDiseaseDoseDrug KineticsEnzymesFDA approvedFatty acid glycerol estersFibrosisGlucocorticoidsGlycolsHepaticHepatocyteHepatomegalyHistologyHospitalsHumanHydroxylationIcterusIn VitroInfectionInfiltrationInflammatoryInflammatory ResponseInjuryIntracellular Accumulation of LipidsKnowledgeLifeLinkLipidsLiverLiver RegenerationMalaiseMalnutritionMetabolic DiseasesMitochondriaMorbidity - disease rateMultiple Organ FailureNatural regenerationPathway interactionsPatientsPentoxifyllinePlacebosPrednisonePrevalenceSafetySignal PathwaySignal TransductionSterolsSulfateSyndromeSystemic Inflammatory Response SyndromeTherapeutic Agentsbasecell injuryeffective therapyhepatocellular injuryhigh riskimprovedin vivolipid biosynthesislipid metabolismliver cell proliferationmacrophagemortalitymouse modelnon-alcoholic fatty liver diseasenonalcoholic steatohepatitisnovelnovel therapeuticsopen labelorgan injuryoverexpressionpilot trialpre-clinicalpreclinical studystandard of caresulfotransferasetreatment guidelines
项目摘要
AH is an acute form of alcoholic liver disease and includes a spectrum that ranges from mild injury to severe,
life threatening injury. The prevalence of AH has not been accurately determined; it is believed to occur in 10%
to 35% of heavy drinkers. On histology, AH is characterized by infiltration of the liver by inflammatory cells and
hepatocellular injury. AH is usually associated with progressive fibrosis in the presence of continued alcohol
abuse. No new drugs for AH have been successfully developed since the introduction of corticosteroids as a
treatment in the early 1970s. Corticosteroids have been utilized as a standard of care in various treatment
guidelines for patients with severe AH. Pentoxifylline has also been used because of its safety, but several
well-conducted studies have not supported the efficacy of pentoxifylline for the treatment of severe AH.
Importantly, a recent study has questioned the efficacy of both prednisone and pentoxifylline in the treatment of
AH. Mortality at 6 months was similar in patients on either prednisone, pentoxifylline, or both as compared with
placebo. Therefore, there is a need for novel therapies. DUR-928 is an endogenous intracellular regulatory
molecule and sulfated oxysterol: 5-cholesten-3β, 25-diol 3-sulfate (25HC3S). DUR-928 is under development
for multiple indications including treatment of chronic metabolic disease, such as NAFLD/NASH and PSC, and
treatment of acute organ injuries, such as AKI and AH. DUR-928 is able to lower intracellular lipid
accumulation, regulate inflammatory responses, and improve cell survival. Based on the current accumulated
knowledge of DUR-928 biology, we believe that DUR-928 represents a novel therapeutic agent for AH with an
excellent safety profile (is produced endogenously). In this PILOT UO1, we propose 2 independent, but linked
studies.
Study #1: An open-label, dose escalation study to assess the safety, pharmacokinetics and efficacy of DUR-
928 in patients with Moderate Alcoholic Hepatitis.
Study #2: An open-label, dose escalation study to assess the safety, pharmacokinetics and efficacy of DUR-
928 in patients with Severe Alcoholic Hepatitis.
AH是一种急性形式的酒精性肝病,包括从轻度损伤到严重损伤的范围,
项目成果
期刊论文数量(0)
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会议论文数量(0)
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CRAIG J. MCCLAIN其他文献
CRAIG J. MCCLAIN的其他文献
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{{ truncateString('CRAIG J. MCCLAIN', 18)}}的其他基金
Inflammation Resolving Lipid Mediators: Novel Therapy for Alcohol AssociatedLiver Disease
消炎脂质介质:酒精相关性肝病的新疗法
- 批准号:
10590047 - 财政年份:2023
- 资助金额:
$ 6.94万 - 项目类别:
Administrative Supplement to Hepatobiology and Toxicology COBRE
肝生物学和毒理学 COBRE 行政增刊
- 批准号:
10399887 - 财政年份:2021
- 资助金额:
$ 6.94万 - 项目类别:
Alcoholic Hepatitis Network 3/9 University of Louisville
酒精性肝炎网络 3/9 路易斯维尔大学
- 批准号:
9752421 - 财政年份:2018
- 资助金额:
$ 6.94万 - 项目类别:
Alcoholic Hepatitis Network 3/9 University of Louisville
酒精性肝炎网络 3/9 路易斯维尔大学
- 批准号:
10434741 - 财政年份:2018
- 资助金额:
$ 6.94万 - 项目类别:
Alcoholic Hepatitis Network 3/9 University of Louisville
酒精性肝炎网络 3/9 路易斯维尔大学
- 批准号:
10202391 - 财政年份:2018
- 资助金额:
$ 6.94万 - 项目类别:
The Role of Nutrition in the Development/Progression of Alcohol-Induced Organ Injury
营养在酒精引起的器官损伤的发生/进展中的作用
- 批准号:
10056411 - 财政年份:2016
- 资助金额:
$ 6.94万 - 项目类别: