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

Phase 2

Completed

• Conditions: Sickle Cell Disease; Vaso-occlusive Crisis; Acute Chest Syndrome
• Interventions: Other: Placebo; Drug: A-001

• Registration Number: NCT00434473
• Lead Sponsor: Anthera Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-13
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Disposition First Submitted: 2012-01-31
• Disposition First Submitted QC: 2012-01-31
• Disposition First Posted: 2012-02-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
A-001	A-001	-

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of different doses of A 001 therapy when administered as a 2-day continuous infusion to sickle cell disease (SCD) patients at-risk for the acute chest syndrome (ACS).	Study end

Secondary Outcome Measures

Name	Time	Method
To confirm the ability of A-001 infusion to suppress serum sPLA2 activity in SCD patients with elevated serum sPLA2	Study end
To determine the pharmacokinetic profile of A-001 in SCD patients	Study end
To determine the efficacy of A-001 infusion in preventing ACS in SCD patients with the combination of vaso-occlusive crisis (VOC), fever, and elevated serum sPLA2	Study end

Trial Locations

Locations (6)

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States

Duke University Comprehensive Sickle Cell Center; 🇺🇸 Durham, North Carolina, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States