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临床试验/NCT02108262
NCT02108262已完成2 期

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

CSL Behring378 个研究点 分布在 2 个国家目标入组 1,267 人开始时间: 2014年8月最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
CSL Behring
入组人数
1,267
试验地点
378
主要终点
Percent of Participants With Clinically Important Change in Renal Status
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.

排除标准

  • •Ongoing hemodynamic instability
  • •Evidence of hepatobiliary disease
  • •Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
  • •Evidence of unstable renal function
  • •History of acute kidney injury after previous exposure to an intravenous contrast agent.
  • •Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
  • •Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

结局指标

主要结局

Percent of Participants With Clinically Important Change in Renal Status

时间窗: From baseline (before first infusion) to Day 29.

A clinically important change in renal status is defined as a serum creatinine (Cr) increase to ≥ 1.5 x the baseline value that is confirmed upon repeat measurement.

Percent of Participants With Clinically Important Change in Drug-induced Liver Injury

时间窗: From baseline (before first infusion) to Day 29.

A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement.

次要结局

  • The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)(From the start of the first infusion up to approximately 382 days)
  • Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants(Before first infusion and end of first infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before and for 7 days after the first infusion)
  • Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before and for 7 days after the fourth infusion)
  • Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants(Before first infusion and end of fourth infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants(Before and for 7 days after the fourth infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before and for 7 days after the fourth infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before and for 7 days after the first infusion)
  • Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function(Before first infusion and end of first infusion)
  • Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function(Before first infusion and end of fourth infusion)
  • Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion and end of fourth infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment(Before first infusion and end of first infusion)
  • Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants(Before and for 7 days after the first infusion)
  • Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Percent of Participants Who Experience Bleeding Events(From the start of first infusion, up to approximately Day 112)
  • Number of Participants With Parvovirus B19 DNA in Serum(Study Day 112)
  • Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Percent of Participants With Any Adverse Event (AE)(From the start of first infusion, up to approximately Day 382)
  • Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19(Study Day 112)
  • Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after first infusion)
  • Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment(Before first infusion (baseline) and for up to approximately 7 days after fourth infusion)
  • Change From Baseline in Serum Antibodies to CSL112 and apoA-I(Before first infusion, up to approximately Day 112)
  • Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions(From the start of first infusion, up to approximately Day 382)

研究者

发起方
CSL Behring
申办方类型
Industry
责任方
Sponsor

研究点 (378)

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