EUCTR2007-002035-81-CZ进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- •Candidates for this study must meet ALL of the following criteria:
- •1. Clinical objective evidence of bacterial infection and being treated with
- •antimicrobial medication (s). Evidence would include but is not limited to:
- •Physical exam findings (i.e. cellulitis or abscesses)
- •Gram stains
- •Radiographic studies
- •Surgical pathology specimens
- •** Note: A positive culture is not required for eligibility
- •2. DIC score of =3 using a modified ISTH algorithm documented within 24 hours of
- •study drug administration.
- •3. Subject presents with 2 or more of the following sepsis related SIRS criteria within
- •24 hours prior to any particular qualifying DIC score, with one of the two criteria
- •being either temperature or WBC:
- •a. Temperature >38ºC or <36ºC (core temperature for low range temperature)
- •b. WBC >12,000 or <4,000 cells/µL or >10% Band forms
- •c. Heart Rate >90 BPM (This criterion cannot be used if the subject is treated with
- •ß-blockers or heart rate is pacemaker dependent)
- •d. Respiratory Rate >20 BPM or PaCO2<32 mmHg or mechanically ventilated
- •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
- •Candidates for the study will be excluded if ANY of the following criteria are present:
- •1. Subject or Legally Authorized Representative is unable to provide informed consent
- •2. Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study
- •3. Subject is of childbearing potential and does not agree to use a medically acceptable form of contraception for the duration of the trial (28 days or 22 days post the last dose of study drug administration). (see protocol for further details)
- •4. Subject is < 18 years of age
- •5. Allergy to ART-123 or any components of the drug product
- •6. Subject is unwilling to allow transfusion of blood or blood products
- •7. Presence of an advance directive to withhold life-sustaining treatment, with the exception of cardiopulmonary resuscitation (CPR)
- •8. Previous treatment with ART-123
- •9. Body weight = 175kg
- •10. PT prolongation or thrombocytopenia that is not due to sepsis (see protocol for further details)
- •11. Intra-thoracic, intra-abdominal, or intra-cranial surgery, within the previous 12 hours to randomization, or ongoing impairment of hemostasis as a result of one of these procedures
- •12. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to enrollment (see protocol for further details)
- •13. Cerebral Vascular Accident (CVA) within 3 months prior to enrollment
- •14. Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system
- •15. A history of congenital bleeding diatheses
- •16. Gastrointestinal bleeding within 6 weeks prior to enrollment unless a corrective interventional procedure has been performed
- •17. Known medical conditions associated with a hypercoagulable state, including:
- •a. Resistance to activated protein C or known Factor V Leiden
- •b. Hereditary deficiency of protein C, protein S or antithrombin III
- •c. Presence of anticardiolipin antibody, antiphosopholipid antibody, lupus anticoagulant, prothrombin gene mutation, or homocysteinemia
- •d. Deep-vein thrombois or pulmonary embolism within 3 months prior to enrollment (if evaluation is in progress, this should be completed before consideration for this trial)
- •e. History of idiopathic thrombosis
- •18. Known or suspected severe liver disease, as defined by a score of 10-15 (class C) using the Child-Pugh Classification (see Appendix G of protocol)
- •19. Portosystemic hypertension or known history of bleeding esophageal varices
- •20. History of solid organ, allogeneic bone marrow, or stem cell transplantation within 6 months of enrollment (uncomplicated kidney and autologous stem cell/bone marrow transplant subjects may be enrolled at any time after they have recovered from their transplant procedure)
- •21. Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture. Also, in the opinion of the treating physician the subject is at an increased risk for developing hemorrhagic pancreatitis over the duration of the study.
- •22. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
- •23. Use or intended use of Xigris® (drotrecogin alfa [activated]) within the 24 hours prior of enrollment
- •24.Use or intended use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 24 hours prior to study dosing with the exception of:
- •a. Heparin locks/flushes
- •b. DVT Prophylaxis with
研究者
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