Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021502
Status:
COMPLETED
Last Update Posted:
2009-08-14
First Post:
2001-07-18
Brief Title:
Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome SIRS
Sponsor:
Apex Bioscience
Organization:
Apex Bioscience
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Placebo Controlled Study of PHP When Administered by Continuous Infusion in Patients With Shock Associated With Systemic Inflammatory Response Syndrome SIRS
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate PHP administered by continuous intravenous IV infusion in systemic inflammatory response syndrome SIRS patients with shock PHP is a human-derived chemically modified hemoglobin preparation PHP selectively scavenges excess nitric oxide NO and does so in a catalytic concentration-dependent reaction that results in the formation of the non-toxic NO metabolite nitrate PHP is postulated to reduce excess toxic levels of NO while allowing critical beneficial levels of the molecule to persist
Detailed Description:
This Phase 3 randomized placebo controlled multi-center study is designed to evaluate the safety and efficacy of continuous IV infusion of PHP plus conventional vasopressor treatment as compared to continuous IV infusion of Plasma-Lyte A plus conventional vasopressor as a treatment for restoring hemodynamic stability in SIRS patients with shock Conventional vasopressors include dopamine 5 mcgkgmin or norepinephrine phenylephrine or epinephrine at any dose
The study consists of a Screening period a Pre-Treatment period and a 28-day Treatment period Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period
The safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of
all cause mortality
median patient survival time and
adverse event rates and duration
The study consists of a Screening period a Pre-Treatment period and a 28-day Treatment period Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period
The safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of
all cause mortality
median patient survival time and
adverse event rates and duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None