NCT00434473

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome (Dose Escalation Study: Varespladib Infusion [A-001] for the Prevention of Acute Chest Syndrome in At-Risk Patients With Sickle Cell Disease and Vaso-occlusive Crisis)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.

Detailed description

This is a double-blind randomized, parallel group, placebo-controlled dose escalation study (2 cohorts) in patients with sickle cell disease (SCD) and vaso-occlusive crisis (VOC) who are at-risk for development of acute chest syndrome (ACS) based on the combination of VOC, fever (T ≥38.0ºC), and a serum sPLA2 concentration ≥50 ng/mL. The first group of patients will be randomized 2:1 to receive low dose A-001 or placebo as a 48-hour continuous infusion. Pharmacokinetic and clinical data from this group will undergo review by the Independent Data Monitoring Committee (IDMC). If there is no significant toxicity associated with A-001, then an additional group of patients will be enrolled and randomized 2:1 to high dose A-001 versus placebo as a 48-hour continuous infusion.

Conditions

• Sickle Cell Disease
• Vaso-occlusive Crisis
• Acute Chest Syndrome

Interventions

Type	Name	Description
DRUG	A-001	A-001
OTHER	Placebo	Placebo

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2007-02-13
• Last updated: 2014-03-04

Locations

6 sites across 1 country: United States