Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 3:54 PM
Study NCT ID:
NCT00563134
Status:
SUSPENDED
Last Update Posted:
2010-07-07
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Trial on the Saftely and Efficacy of GR270774 in the Treatment of Gram-negative Sepsis in Adult
Sponsor:
Hospital Authority, Hong Kong
Organization:
Study Overview
Official Title:
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
Status:
SUSPENDED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HARECCTR0500030 | None | None | View |