(GR-270773)-药物靶点：Endotoxin_专利_临床

概要

基本信息

药物类型

小分子化药

别名

GR-270773-Emulsion、GR 270773X、GR 270773

靶点

Endotoxin(内毒素)

作用机制

内毒素抑制剂

治疗领域

感染、泌尿生殖系统疾病、其他疾病

在研适应症-

非在研适应症

疲劳、终末期肾脏病、脓毒症+ [1]

原研机构

Sepsicure, L.L.C.

在研机构-

非在研机构

GSK PlcSepsicure, L.L.C.

最高研发状态(全球)终止临床2期

首次获批日期(全球)-

最高研发状态(中国)无进展

特殊审评-

关联

5

项与 GR-270773 相关的临床试验

NCT00506454 / Completed临床2期

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study of the Effects of a Lipid Emulsion (Lipidose) on Endotoxin Levels in Patients on Chronic Hemodialysis

The purpose of this study is to determine whether a phospholipid emulsion is effective in the treatment of chronic endotoxemia in hemodialysis patients.

开始日期2007-08-01

申办/合作机构

Sepsicure, L.L.C.

[+1]

NCT00563134 / SuspendedN/AIIT

A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults

Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic substances (toxins) from bacteria and other germs entering your bloodstream. Most people with sepsis will recover with routine medical care before the illness gets more serious. However, in some people, sepsis does become more serious. This severe sepsis can cause damage to internal organs (such as your heart, lungs, kidneys, and liver) and can be life threatening. Special natural fats, (called 'lipoproteins') in our blood are thought to help protect us from the toxins produced by bacteria during sepsis. Levels of these lipoproteins are often low in people with sepsis and this may make it more difficult to recover from the disease. GR270773 is a new drug that has been developed to help the lipoproteins in protecting the body against toxins. GR270773 is made from purified fats and oils from the soyabean and does not contain cholesterol. This research study will test the safety (side effects) of GR270773 and whether or not it is effective in preventing complications in people with severe sepsis.

开始日期2005-10-01

申办/合作机构

Hospital Authority (Hong Kong)

[+1]

NCT00158769 / Completed临床1期

An Open-Label, Non-Randomised, Pharmacokinetic, Metabolic Disposition and Safety Study of a 3 Day Continuous Infusion of GR270773 in Healthy Subjects and Subjects With Hepatic Impairment.

This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver. This study is designed to see whether the effect of the drug in people with poorly functioning livers is any different to the effect on healthy adults.

开始日期2005-03-31

申办/合作机构

GSK Plc

100 项与 GR-270773 相关的专利（医药）

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1

项与 GR-270773 相关的文献（医药）

2009-11-01·Critical Care Medicine1区 · 医学

Efficacy and safety of a phospholipid emulsion (GR270773) in Gram-negative severe sepsis: Results of a phase II multicenter, randomized, placebo-controlled, dose-finding clinical trial

1区 · 医学

Article

作者: Phillip Dellinger, R. ; Tomayko, John F. ; Angus, Derek C. ; Opal, Steven ; Cupo, Michael A. ; McDermott, Sharon ; Ducher, Annie ; Calandra, Thierry ; Cohen, Jonathan

OBJECTIVE:

To assess the survival benefit and safety profile of low-dose (850 mg/kg) and high-dose (1350 mg/kg) phospholipid emulsion vs. placebo administered as a continuous 3-day infusion in patients with confirmed or suspected Gram-negative severe sepsis. Preclinical and ex vivo studies show that lipoproteins bind and neutralize endotoxin, and experimental animal studies demonstrate protection from septic death when lipoproteins are administered. Endotoxin neutralization correlates with the amount of phospholipid in the lipoprotein particles.

DESIGN:

A three-arm, randomized, blinded, placebo-controlled trial.

SETTING:

Conducted at 235 centers worldwide between September 2004 and April 2006.

PATIENTS:

A total of 1379 patients participated in the study, 598 patients received low-dose phospholipid emulsion, and 599 patients received placebo. The high-dose phospholipid emulsion arm was stopped, on the recommendation of the Independent Data Monitoring Committee, due to an increase in life-threatening serious adverse events at the fourth interim analysis and included 182 patients.

MEASUREMENTS AND MAIN RESULTS:

A 28-day all-cause mortality and new-onset organ failure. There was no significant treatment benefit for low- or high-dose phospholipid emulsion vs. placebo for 28-day all-cause mortality, with rates of 25.8% (p = .329), 31.3% (p = .879), and 26.9%, respectively. The rate of new-onset organ failure was not statistically different among groups at 26.3%, 31.3%, 20.4% with low- and high-dose phospholipid emulsion, and placebo, respectively (one-sided p = .992, low vs. placebo; p = .999, high vs. placebo). Of the subjects treated, 45% had microbiologically confirmed Gram-negative infections. Maximal changes in mean hemoglobin levels were reached on day 10 (-1.04 g/dL) and day 5 (-1.36 g/dL) with low- and high-dose phospholipid emulsion, respectively, and on day 14 (-0.82 g/dL) with placebo.

CONCLUSIONS:

Treatment with phospholipid emulsion did not reduce 28-day all-cause mortality, or reduce the onset of new organ failure in patients with suspected or confirmed Gram-negative severe sepsis.

研发状态

适应症	最高研发状态	国家/地区	公司
脓毒症	终止	斯洛伐克更多	GSK Plc 更多
感染性休克	终止	英国更多	-
疲劳	无进展	美国更多	Sepsicure, L.L.C. 更多
终末期肾脏病	无进展	美国更多	Sepsicure, L.L.C. 更多