NL-OMON54454招募中3 期
A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial) - PB2452-PT-CL-0004 (REVERSE-IT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female > 18 years of age with documented or verbal informed
- •consent. Emergency consent may be obtained where permitted by local regulations
- •and institutional approval. 2. History or documentation of ticagrelor intake
- •within the prior 3 days 3. Patients described below who require urgent reversal
- •of the antiplatelet effects of ticagrelor: Patients with uncontrolled major or
- •life-threatening bleeding, requiring urgent reversal of the antiplatelet
- •effects of ticagrelor. It is expected that enrolled patients would have
- •characteristics similar to those described below: • Potentially
- •life-threatening bleeding with signs or symptoms of hemodynamic compromise,
- •e.g., systolic blood pressure < 90 mm Hg and signs or symptoms of low
- •cardiac output not otherwise explained • Bleeding in a critical organ or closed
- •space, such as intracranial, intraspinal, intraocular, retroperitoneal, intra*
- •articular, pericardial, or intramuscular bleed with compartment syndrome •
- •Visible, uncontrolled bleeding associated with a corrected hemoglobin level
- •< 8.0 g/dL, a fall in hemoglobin level of >= 2.0 g/dL (1.24 mmol/L) from a
- •known baseline, or requirement for transfusion of 2 or more units of packed red
- •blood cells (PRBC) Patients requiring urgent surgery or invasive procedure when
- •it is not medically advisable either to proceed urgently with impaired
- •hemostasis or to delay the urgent procedure for 3 or more days due to the high
- •risk of bleeding. These patients may typically be in any of the following
- •clinical situations: • Requires urgent surgery or invasive procedure known to
- •be associated with a risk of significant bleeding (such as cardiac surgery,
- •neurosurgery, or major orthopedic surgery) • Requires urgent surgery or
- •invasive procedure that may have an adverse procedural outcome if hemostasis is
- •impaired (such as neurological, spinal, ophthalmological, urological, or
- •orthopedic surgery) • At risk of experiencing life-threatening events, such as,
- •shock, myocardial infarction, or stroke, if significant intraoperative or
- •postoperative bleeding occurs (such as in elderly patients or patients with
- •underlying cardiac or pulmonary disease who have limited cardiopulmonary
排除标准
- •1. Known sensitivity or contraindication to PB2452 or any of its excipients 2.
- •Patients in whom ticagrelor reversal is not considered urgent, e.g., patients
- •with stable or non-acute conditions who have low hemoglobin due to chronic,
- •low-grade gastrointestinal bleeding or who have stable, remote, or asymptomatic
- •intracranial hemorrhage. 3. Patients expected to be clinically unsalvageable,
- •such as patients with end-stage cancer or patients with overwhelming sepsis. 4.
- •Any condition which, in the opinion of the investigator, would make it unsafe
- •or unsuitable for the patients to participate in this study. This includes
- •assessment of likelihood to cooperate with study follow-up visits and
- •procedures • Known pregnancy may be exclusionary in some regions or countries
- •as directed by national health authorities and/or local IRBs/Ethics Committees
- •5. Known use of clopidogrel, prasugrel, or ticlopidine within 5 days of study
- •drug administration; known use of antiplatelet GPIIb/IIIa inhibitors, or
- •cangrelor within 5 half-lives of study drug administration; or known use of
- •warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 5 half-lives of
- •expected study drug administration 6. Known recent use (< 5 day) of vitamin
- •K, prothrombin complex concentrate, recombinant factor VIIa, idarucizumab, or
- •andexanet-alfa (coagulation factor Xa (recombinant), inactivated-zhzo).
研究者
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