Clinical Trial: A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-Controlled Study With Varespladib Infusion (A-001) in Subjects With Sickle Cell Disease and Vaso-Occlusive Crisis for the Prevention of Acute
Brief Summary: The purpose of this study is to determine the effectiveness of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).
Detailed Summary:
Sponsor: Anthera Pharmaceuticals
Current Primary Outcome: Efficacy of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with the combination of vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP). [ Time Frame: Various time points up to Day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome. [ Time Frame: Various time points up to Day 30 ]
- Impact of A-001 treatment on sPLA2 levels and CRP. [ Time Frame: Various time points up to Day 30 ]
- Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis. [ Time Frame: Various time points up to Day 30 ]
- Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis. [ Time Frame: Various time points up to Day 30 ]
Original Secondary Outcome: Same as current
Information By: Anthera Pharmaceuticals
Dates:
Date Received: January 18, 2012
Date Started: February 2012
Date Completion:
Last Updated: January 30, 2014
Last Verified: January 2014
