EUCTR2007-007861-19-BG进行中（未招募）不适用
An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal ofcoagulopathy induced by coumarin derivatives in subjects with acute major bleeding
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects = 18 years,
- •Subjects who have received anticoagulation therapy (warfarin,
- •acenocoumarol or phenprocoumon) ,
- •Subjects who have acute major bleeding, defined as one of the
- •o Life-threatening or potentially life-threatening,
- •o Acute bleeding associated with a fall in Hb level =
- •o Bleeding requiring blood product transfusion (blood
- •products include plasma, red blood cells and other
- •coagulation factor products),
- •INR = 2 within 3 hours before start of study treatment,
- •Informed consent has been obtained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Expected survival of less than 3 days, or expected surgery? in
- •less than 1 day,
- •Acute trauma for which reversal of vitamin K antagonists
- •alone would not be expected to control the acute bleeding
- •For patients with ICH:
- •o Glasgow coma score < 9,
- •o Intracerebral hematoma volume > 30cc as assessed by
- •o For subdural hematomas: maximum thickness = 10
- •mm, midline shift = 5 mm,
- •o For subarachnoid hemorrhage: any evidence of
- •hydrocephalus,
- •o Infratentorial ICH location,
- •o Epidural hematomas,
- •o Intraventricular extension of hemorrhage,
- •o Modified Rankin score of >3 prior to ICH,
- •History of thrombotic event, myocardial infarction,
- •disseminated intravascular coagulation, cerebral vascular
- •accident, transient ischemic attack, unstable angina pectoris,
- •or severe peripheral vascular disease within 3 months of
- •enrollment,
- •Known history of antiphospholipid antibody syndrome or
- •lupus anticoagulant antibodies,
- •Suspected or confirmed sepsis at time of enrollment,
- •Administration of whole blood, plasma, plasma fractions or
- •platelets within 2 weeks prior to inclusion into the study
- •o Note: Administration of packed red blood cells is not
- •an exclusion criterion,
- •Large blood vessel rupture (e.g. in advanced cancer patient),
- •Pre-existing progressive fatal disease with a life expectancy of
- •less than 2 months,
- •Known inhibitors to coagulation factors II, VII, IX, or X; or
- •hereditary protein C or protein S deficiency; or heparininduced,
- •type II thrombocytopenia,
- •Treatment with any other investigational medicinal product
- •within 30 days prior to inclusion into the study,
- •Presence or history of hypersensitivity to components of the
- •study medication,
- •Pregnant or breast-feeding women,
- •Prior inclusion in this study or any other CSL Behring
- •sponsored Beriplex study.
- •?Subjects with acute major bleeding requiring minimal invasive
- •procedures (e.g. endoscopy, bronchoscopy, central lines) that are
- •indicated for diagnostic or therapeutic reasons are not excluded
- •per protocol, as long as plasma is intended to be given for
- •treatment of major bleeding.
研究者
相似试验
进行中（未招募）
不适用
A study to assess the efficacy of Beriplex P/N compared with plasma for quick reversal of anticoagulant medicines in patients who require an urgent surgeryPerioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and SMedDRA version: 14.1Level: PTClassification code 10065667Term: Haemorrhage prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10009789Term: Coagulation factors decreasedSystem Organ Class: 100000004848EUCTR2007-007862-39-BGCSL Behring GmbH176
进行中（未招募）
不适用
An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects with acute major bleeding.This study looks into the therapy of major bleeding resulting from an acquired deficiency of vitamin K-dependant coagulation factors and proteins C and S due to use of oral anticoagulation therapy.MedDRA version: 9.1Level: LLTClassification code 10009789Term: Coagulation factors decreasedMedDRA version: 9.1Level: LLTClassification code 10005103Term: BleedingEUCTR2007-007861-19-PLCSL Behring GmbH176
进行中（未招募）
不适用
An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of Beriplex P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects requiring emergency surgery or invasive intervention - NDPerioperative prophylaxis for emergency surgery or invasive intervention in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S due to use of oral anticoagulationMedDRA version: 9.1Level: HLTClassification code 10009737EUCTR2007-007862-39-ITCSL BEHRING GmbH176
进行中（未招募）
不适用
A open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects requiring emergency surgery or invasive intervention.EUCTR2007-007862-39-PLCSL Behring GmbH176
进行中（未招募）
不适用
A global and multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with chemotherapy (cisplatin/capecitabine), as therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.Metastatic HER2-positive adenocarcinoma of the stomach or gastro-esophageal junction.MedDRA version: 16.0Level: LLTClassification code 10071114Term: Metastatic gastric adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001526-19-CZF.Hoffmann-La Roche Ltd406