NCT01522196终止2 期
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 Chest Syndrome At-Risk Subjects.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotypes Hb SS, Hb SC, sickle β°-thalassemia, sickle β+ -thalassemia
- •Pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes
- •Serum CRP ≥5.0 mg/L at time of screening
- •Fever defined as oral temperature ≥38.0°C at time of screening
- •Age ≥5 years
排除标准
- •New or suspected new pulmonary infiltrate diagnosed by chest radiography
- •Females who are nursing, pregnant or intend to become pregnant
- •Renal dysfunction defined as a creatinine level >1.2 mg/dL for subjects aged 18 or less or a creatinine level >1.5 mg/dL for subjects over the age of 18
- •Hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 × 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 prior to screening
- •Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening
研究组 & 干预措施
Varespladib
Active Comparator
48 hour continuous infusion delivered intravenously (IV)
干预措施: Varespladib (Drug)
Placebo
Placebo Comparator
48 hour continuous infusion delivered intravenously (IV)
干预措施: Placebo (Normal Saline) (Other)
结局指标
主要结局
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).
时间窗: Various time points up to Day 30
次要结局
- Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.(Various time points up to Day 30)
- Impact of A-001 treatment on sPLA2 levels and CRP.(Various time points up to Day 30)
- Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.(Various time points up to Day 30)
- Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.(Various time points up to Day 30)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Prevention Of Recurrence Of Atrial FibrillationFibrillation, AtrialNCT00041496GlaxoSmithKline520
已完成
2 期
An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old AdultsHealthyNCT03334695Janssen Vaccines & Prevention B.V.64
终止
2 期
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and OlderRespiratory Syncytial VirusesRespiratory Tract DiseasesNCT03982199Janssen Vaccines & Prevention B.V.5,815
已完成
1 期
Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in BrazilH7N9 InfluenzaInfluenzaNCT03330899Butantan Institute432
进行中（未招募）
2 期
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT06736990Calluna Pharma AS150