IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome
1 other identifier
interventional
30
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2006
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 4, 2014
January 1, 2014
2.7 years
February 9, 2007
January 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
To determine the pharmacokinetic profile of A-001 in SCD patients
Study end
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 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
Study Arms (2)
Placebo
PLACEBO COMPARATORA-001
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- New lung infiltrate by chest radiography
- Pregnancy or breastfeeding
- Significant renal dysfunction
- Significant hepatic dysfunction
- Acute neurologic dysfunction
- Any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dL
- Red blood cell transfusion within 30 days of entry into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Duke University Comprehensive Sickle Cell Center
Durham, North Carolina, 27713, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 13, 2007
Study Start
December 1, 2006
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
March 4, 2014
Record last verified: 2014-01