NCT02074995终止2 期
Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
详细描述
No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
- •Dosing must occur within 8-12 days post-burn
- •Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study
排除标准
- •Spinal cord injury
- •Hypoxic brain injury (Glasgow Coma Scale (GCS) <8) at screening
- •True conductive electric burn with suspected neurologic injury
- •Uncontrolled diabetes with HbA1c > 10% at screening, or known history of hypoglycemia,
- •History of or active peripheral neuropathy or seizure disorder
- •Systemic corticosteroids : > 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists
结局指标
主要结局
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
时间窗: Over 1 year
Number of patients with adverse events as a measure of safety and tolerability
Efficacy Measure by Change in Lean Body Mass (LBM)
时间窗: Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106
Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.
次要结局
- Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life(Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
- Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration(Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105)
研究者
研究点 (2)
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