NCT01868685撤回2 期
An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in thigh muscle thickness
研究概览
简要总结
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for >24 hours.
- •Expected to survive at least 14 days.
- •Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status).
排除标准
- •Patients deemed to be terminal wean patients.
- •Patients who have progressive neuromuscular degenerative disorders.
- •Patients who are comatose.
- •Evidence of unstable medical status.
研究组 & 干预措施
BYM338
Experimental
干预措施: BYM338 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in thigh muscle thickness
时间窗: After 14 days
次要结局
- Number of patients with adverse events as a measure of safety and tolerability(After 12 weeks)
- Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients(After 12 weeks)
研究者
相似试验
已完成
2 期
A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic AdultsSkeletal MuscleNCT01601600Novartis Pharmaceuticals40
已完成
2 期
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With CachexiaChronic Obstructive Pulmonary Disease (COPD) With CachexiaNCT01669174Novartis Pharmaceuticals67
已完成
2 期
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the PancreasCachexiaNCT01433263Novartis Pharmaceuticals57
已完成
2 期
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body MyositisSporadic Inclusion Body MyositisNCT01423110Novartis Pharmaceuticals14
已完成
1 期
A Study of Experimental Medication BMS-986278 Given to Healthy ParticipantsHealthy ParticipantsNCT03429933Bristol-Myers Squibb112