Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure
The purpose of this study is to determine the effect of resatorvid on subjects with sepsis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis-Induced Cardiovascular and Respiratory Failure|
- All-cause Mortality [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]Mortality regardless of cause at Day 28
- ICU Free Days [ Time Frame: Day 28 ] [ Designated as safety issue: No ]Number days participant was not in ICU
- Vasopressor Free Days. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]Number days participant did not need vasopressors.
- Ventilator Free Days. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]Number days participant was not on Ventilattor support.
|Study Start Date:||February 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
|Experimental: Resatorvid 2.4 mg/kg/day||
Resatorvid 1.2 mg/kg emulsion, injection for 30 minutes and resatorvid 2.4 mg/kg per-day emulsion, injection, continuous infusion for 96 hours.
Other Name: TAK-242
|Placebo Comparator: Placebo||
Resatorvid placebo-matching emulsion, injection for 30 minutes and resatorvid placebo-matching emulsion, injection, continuous infusion for 96 hours.
Sepsis is a major cause of in-hospital death, with a higher mortality rate than events such as stroke and acute myocardial infarction, each with less than a 20% risk of death in the first 30 days. Sepsis is a clinical condition caused by the innate inflammatory host response to systemic infection that can result in organ failure and potentially death. Under certain circumstances, many components of the innate immune response that are normally involved with host defense can cause cell and tissue damage and subsequently multiple organ failure, the clinical hallmark of severe sepsis.
The host response to infection is characterized by the synthesis and release of proinflammatory cytokines. Cytokines are released by signals transmitted from the surface of inflammatory cells, after binding of pathogen-associated molecules to cell surface pattern recognition receptors known as toll-like receptors.
TAK-242 (resatorvid) is a toll-like receptor 4 inhibitor under clinical development for the treatment of patients with severe sepsis. Study participation is anticipated to be about 28 days, with an additional 9 month follow-up period.