NCT00021502

Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (planned)
• Sponsor: Apex Bioscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 mcg/kg/min; 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.

Conditions

• Shock
• Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
DRUG	pyridoxalated hemoglobin polyoxyethylene conjugate (PHP)

Timeline

• Start date: 2001-03-01
• Primary completion: 2003-08-01
• Completion: 2004-05-01
• First posted: 2001-07-20
• Last updated: 2009-08-14