NCT02281201已完成3 期
An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 11
- 试验地点
- 22
- 主要终点
- Percentage of Subjects With a Rapid Reversal of VKA Effect
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who require immediate correction of international normalized ratio (INR) due to a major bleed or emergency surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Japanese subjects greater than or equal to 20 years
- •Subjects currently on vitamin K antagonist (VKA) therapy
- •INR greater than or equal to 2 within 3 hours before start of BE1116 infusion
- •Urgent reversal of VKA therapy for a surgical or invasive medical procedure is required within 24 hours of the start of BE1116 infusion, or presentation with an acute major bleed
排除标准
- •Subjects for whom administration of I.V. vitamin K and VKA withdrawal, alone, can adequately correct the subject's coagulopathy before the infusion of BE1116
- •Subjects in whom lowering the INR to within the normal range is not a treatment goal
- •Use of anticoagulants other than VKAs (or expected use within 1 day)
- •Medical history for which PCCs are contraindicated
- •History of thromboembolic event within 3 months of screening
- •Congenital or acquired abnormality of hemostasis other than receipt of VKAs
- •Administration of whole blood, plasma, plasma fractions, or platelets within 2 weeks prior to the start of BE1116 infusion
- •For subjects with intracranial hemorrhage (ICH):
- •Glasgow Coma Score (GCS) < 7
- •Intracerebral hematoma volume > 30 cm3 as assessed by computed tomography (CT) scan
- •For subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm, or acute subdural hematomas (based on neurosurgeon review)
- •For subarachnoid hemorrhage: any evidence of hydrocephalus, or Hunt and Hess Scale > 2, or concomitant subdural hematoma
- •Infratentorial ICH location
- •Epidural hematomas
- •Intraventricular rupture of hemorrhage
- •Requires surgical intervention
结局指标
主要结局
Percentage of Subjects With a Rapid Reversal of VKA Effect
时间窗: At baseline and at 30 minutes after the end of infusion
A rapid reversal of (Vitamin K antagonist) VKA effect is a reduction of the INR to ≤ 1.3 at 30 minutes after the end of infusion.
次要结局
- 45-Day All-cause Mortality(Until Day 45)
- Overall Treatment-emergent Adverse Events (TEAEs)(From the start of infusion up to the allowed time window of the Day 14 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs)
- Mean Predicted and Actual Blood Loss (mls) for all Surgical/Invasive Procedures(From the start of surgery/procedure until the end of surgery/procedure)
- Mean Time (mins) Between Last Suture and Cessation of Wound Drainage for all Surgical/Invasive Procedure(From the time of last suture until the end of wound drainage, up to the final safety follow-up visit (Day 45))
- Viral serology(At baseline and until Day 45)
- Mean modified Rankin Scale for all subjects with intracranial haemorrhage(Before infusion and at Day 45)
- Increase in Plasma Levels of Factor (F)II, FVII, FIX, and FX, and Protein C and Protein S(Before infusion and up to 3 h after the start of infusion)
- Percentage of Subjects Who Receive Red Blood Cells(From the start of infusion until 24 h after the start of infusion)
- Vital signs(At baseline and until 24 hours after the end of infusion)
- Percentage of Subjects Achieving Hemostatic Efficacy During Surgery(From the start of surgery/procedure until the end of surgery/procedure)
- Percentage of Subjects Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed(Baseline CT scan, baseline haematology or the end of infusion, until 24 hours after the end of infusion)
- Percentage of Subjects With INR Correction(From the start of infusion until INR correction, up to 24 hours after the end of infusion)
- Percentage of Subjects With INR Correction at Various Times After the End of Infusion(From the end of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the end of infusion)
- Percentage of Subjects Who Receive Other Blood Products and Hemostatic Agents(From the start of infusion until 24 h after the start of infusion)
- Mean Volume (mls) of Wound Drainage for all Surgical/Invasive Procedures(From the start of wound drainage until the end of wound drainage, up to the final safety follow-up visit (Day 45))
研究者
研究点 (22)
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