EUCTR2007-000969-37-GB进行中（未招募）不适用
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3月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
- •- US and UK: age =12 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
排除标准
- •- 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
研究者
相似试验
进行中（未招募）
不适用
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 SyndromeAcute Chest Syndrome (ACS) in At-Risk patients with Sickle Cell Disease (SCD) and Vaso-occlusive Crisis (VOC)MedDRA version: 9.1Level: LLTClassification code 10051895Term: Acute chest syndromeEUCTR2007-000969-37-FRAnthera Pharmaceuticals Incorporated75
尚未招募
2 期
Evaluating GLUBLOC™ for Better Blood Sugar Management in Type 2 DiabetesCTRI/2024/08/072197INU Energy Pvt Ltd
招募中
Unknown
Investigating the effect of regular breathing on anxietyIRCT20240216061027N1Yazd University of Medical Sciences66
招募中
不适用
A preliminary investigation on the effects of intermittent exposure to hypoxia on glucose homeostasisImpaired fasting blood glucosePre-diabetesOverweightType 2 diabetesMetabolic and Endocrine - DiabetesACTRN12616000525482Southern Cross University25
已完成
不适用
The effect of stress on cortisol, endocannabinoids and cognitive processingHPA stress responseMental Health - Studies of normal psychology, cognitive function and behaviourMetabolic and Endocrine - Normal metabolism and endocrine development and functionNeurological - Studies of the normal brain and nervous systemACTRN12618000100291niversity of Tasmania77