Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure

Phase 3

Terminated

• Conditions: Sepsis
• Interventions: Drug: Resatorvid; Drug: Placebo

• Registration Number: NCT00633477
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the effect of resatorvid on subjects with sepsis.

Detailed Description

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-12-05
• Results First Submitted QC: 2012-12-05
• Status Verified: 2013-01
• Results First Posted: 2013-01-09
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resatorvid 2.4 mg/kg/day	Resatorvid	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	Day 28	Mortality regardless of cause at Day 28

Secondary Outcome Measures

Name	Time	Method
ICU Free Days	Day 28	Number days participant was not in ICU
Vasopressor Free Days.	Day 28	Number days participant did not need vasopressors.
Ventilator Free Days.	Day 28	Number days participant was not on Ventilattor support.