EUCTR2007-002035-81-NL进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •To be included in the study, subjects must have infection or suspected
- •infection and must be treated with antimicrobial medication(s) for this
- •specific infection. Additionally, a modified ISTH DIC score of =2
- •related to infection/sepsis using the platelet count and/or INR result plus the presence of at least 2 out of 4 sepsis related SIRS criteria as described below are required.
- •Once the subject presents with an eligible modified DIC score (2 or
- •greater), he/she must have =2 sepsis related SIRS criteria within the 24
- •hours prior to obtaining the eligible DIC score. One of the 2 SIRS criteria must be either temperature criterion or the WBC criterion. Subjects who met SIRS
- •criteria for reasons other than sepsis in the days prior to the current septic
- •episode may be eligible The four SIRS criteria for the purposes of inclusion into this
- •trial are described as the following:
- •Temperature >38ºC or <36ºC (core temperature for low
- •range temperature)
- •Heart Rate >90 BPM (unless the subject is treated with ß-
- •blockers or heart rate is pacemaker dependent. In these
- •cases, only 1 other SIRS criterion, either temperature or the WBC is required)
- •Respiratory Rate >20 BPM or PaCO2<32 mmHg or
- •mechanically ventilated subject
- •WBC >12,000 or <4,000 cells/µL or >10% Band forms
- •If a single INR test or platelet count qualifies the patient, the diagnosis of modified DIC is made the first time such abnormal test is obtained. To use a combination of INR and Platelet count results to meet the modified DIC score of greater than or equal to 2, these two tests must be performed no more than 24 hours apart. The time the latter test is obtained is the time of diagnosis of modified DIC. Regardless if one test qualifies the patient for enrollment, both INR and platelet count must be obtained at screening and documented in the eCRF.
- •Once the patient meets criteria of DIC, a maximum of 36 hours is allowed for consent, randomization and administration of study drug.
- •Platelet count (x 10^3/mm^3):
- •=150 = 0 points
- •=120-<150 = 1 point
- •=80-<120 = 2 points
- •<80 = 3 points
- •Prothrombin time INR:
- •= 1.2 = 0 points
- •>1.2-1.4 = 1 point
- •>1.4-1.6 = 2 points
- •>1.6 = 3 points
- •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
- •Subjects to be excluded from the study are those who meet any of the criteria below:
- •1.Unable to provide informed consent, or lack of consent from an acceptable surrogate in the event that the subject is incapable of providing consent
- •2.Women who are pregnant or breastfeeding or intend to get pregnant within 28 days of enrolling into the study
- •3.Subjects < 18 years of age
- •4.Allergy to ART-123 or any components of the drug product
- •5.Subjects unwilling to allow transfusion of blood or blood products
- •6.Presence of an advance directive to withhold life-sustaining treatment, with the exception of cardiopulmonary resuscitation (CPR)
- •7.Subjects not in a hospital ward or unit with continuous and closely monitored health care that is provided to critically ill subjects (i.e. an Intensive Care Unit, or monitored bed unit with a high nurse to subject ratio 1:2 or 1:3) or in process of being admitted to one
- •8.Previous treatment with ART-123
- •9.Subjects who met inclusion/exclusion criteria more than 36 hours prior to randomization
- •10.Subjects whose INR and platelet count abnormalities improve such that they no longer meet inclusion criteria
- •11. Subjects whose body weight is = 175kg
- •Medical Conditions
- •1.Known conditions that could confound the diagnosis of DIC due to sepsis (see protocol for details)
- •2.Known conditions that increase the risk of bleeding (see protocol for details)
- •3.Known medical condition associated with a hypercoagulable state (see protocol for details)
- •4.Known or suspected severe liver disease (see protocol for details)
- •5.History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
- •6.Acute pancreatitis with no established source of infection
- •7.Severe renal failure characterized by
- •a.chronic renal failure on either hemodialysis, hemofiltration or peritoneal dialysis
- •b.need for acute dialysis
- •Concomitant Medications
- •1.Intended use of Xigris® (drotrecogin alfa [activated]) by treating physician
- •2. All anticoagulants, antiplatelet agents, antithrombotics and thrombolytics are excluded except:
- •a. Heparin locks/flushes
- •b. DVT Prophylaxis with either unfractionated heparin doses no higher than 10000 U SQ within a 24 hour period or with LMWH no higher than recommended prophylactic dose range. However, no switching or alternating between unfractionated heparin and LMWH is allowed during the treatment with study drug and up to Day 14
- •Laboratory Values
- •1.Platelet count <20,000 OR platelet count <30,000 after platelet transfusion.
- •Prognostic Assessment
- •1.Subject’s family, physician, or both not in favor of aggressive treatment of subject or presence of an advance directive to withhold life-sustaining treatment (excluding CPR)
- •2.Subjects who are likely to have limitations put on their life support, given their preexisting, uncorrectable medical condition or who are not expected to survive 90 days due to their underlying medical condition. This would include subjects with, or suspected to have:
- •a.Poorly controlled neoplasms or subjects currently receiving chemotherapy
- •b.New York Heart Association class IV subjects
- •c.Prior cardiac arrest requiring CPR without fully demonstrated neurological recovery, or subject with imminent death
- •d.Vascular disease resulting in severe exercise restriction (i.e., unable to climb stairs or perform household duties), or chronic restrictive or obstructive pulmonary disease that also results in severe exercise restriction, or documented chronic hypoxia, h
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