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

Anthera Pharmaceuticals Incorporated0 个研究点目标入组 75 人开始时间: 2007年4月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Hb SS, Hb SC, sickle ß-thalassemia, sickle ß+ -thalassemia
•- Pain consistent with VOC (clinical judgment) and not attributable to other causes.
•- Serum sPLA2 level =100 ng/mL (measured on-site)
•- Fever defined as oral temperature =38.0°C
•- United States (US): age =12 years (through adult)
•Europe: age =5 years (through adult)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- New (or suspected new) pulmonary infiltrate diagnosed by chest radiography
•- Pregnancy or breastfeeding
•- Known hypersensitivity to any of the active constituents of the A-001 or the IV multivitamin preparation (placebo)
•- Renal dysfunction: creatinine >1.2 mg/dL for age 18 or less, creatinine >1.5 mg/dL for over age 18
•- Hepatic dysfunction (ALT >2 × upper limit of normal)
•- 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
•- Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form
•- Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days of enrollment
•- Treatment with any investigational drug or device in the last 30 days
•- Any other current or past medical condition that might significantly affect pharmacodynamic responses to the administered drug, or any imminently life-threatening illness

发起方

Anthera Pharmaceuticals Incorporated