A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PAHSE 3 STUDY TO ASSESS THE SAFETY AND EFFICACY OF ART-123 IN SUBJECTS WITH SEVERE SEPSIS AND COAGULOPATHY.

ASAHI KASEI PHARMA AMERICA CORPORATION,0 个研究点目标入组 5 人开始时间: 2013年7月26日最近更新: 2023年9月4日

试验速览

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•1. SUBJECT MUST BE RECEIVING TREATMENT IN AN ICU, OR IN ACUTE CARE SETTING (E.G., ER, RECOVERY ROOM) WITH DOCUMENTED ORDERS TO TRANSFER TO THE ICU.
•2. SUBJECTS WHO HAVE CLINICAL EIDENCE OF BACTERIAL INFECTION AND A KNOWN SITE OF INFECTION (WITH OR WITHOUT CONFIRMATION BY CULTURE) AND ALL OF THE FOLLOWING:
•A. CURRENTLY RECEIVING TREATMENT WITH ANTIBIOTICS.
•B. WBC > 12,000/MM³ OR < 4,000/MM³ OR BANDEMIA > 10 %.
•C. PLATELET COUNTS IN THE RANGE OF > 30,000/MM³ TO < 150,000/MM³.
•D. FEVER WITH CORE TEMPERATURE OF < 36° OR > 38°C (IF THE SUBJECT RECEIVED AN ANTIPYRETIC AGENT WITHIN 24 HOURS PRIOR TO SCREENING, THERE MUST BE A DOCUMENTED TEMPERATURE OF GREATER THAN 38°C WITHIN 24 HOURS PRIOR TO ADMINISTRATION OF THE ANTIPYRETIC AGENT IN ORDER TO STILL QUALIFY FOR STUDY PARTICIPATION). AXILLARY TEMPERATURES WILL NOT BE ACCEPTABLE.
•NOTE: THE PRESENCE OF CONCURRENT FUNGAL OR VIRAL INFECTION IS ALLOWED PROVIDED THAT THE PRIMARY REASON FOR TREATMENT IS BACTERIAL INFECTION.
•3. SUBJECTS WITH INFLAMMATORY CHANGES DUE TO SEPSIS DEFINED BY AT LEAST ONE OF THE FOLLOWING:
•I. CARDIOVASCULAR DYSFUNCTION DEFINED AS RECEIVING VASOPRESSORS TO MAINTAIN MEAN ARTERIAL PRESSURE (MAP) GREATER

•1. SUBJECT OR AUTHORIZED REPRESENTATIVE IS UNABLE TO PROVIDE INFORMED CONSENT (AS APPLICABLE PER LOCAL AND COUNTRY REGULATIONS).
•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 HAS A POSITIVE PREGNANCY TEST SINCE ADMISSION TO THE HOSPITAL.
•4. SUBJECT IS < 18 YEARS OF AGE
•5. SUBJECT HAS A KNOWN ALLERGY TO ART-123 OR ANY COMPONENTS OF THE DRUG PRODUCT
•6. SUBJECT IS UNIWILLING TO ALLOW TRANSFUSION OF BLOOD OR BLOOD PRODUCTS
•7. PRESENCE OF AN ADVANCE DIRECTIVE TO WITHHOLD LIFE-SUSTAINING TREATMENT INCLUDING CARDIOPULMONARY RESUSCITATION (CPR)
•8. SUBJECT HAS HAD PREVIOUS TREATMENT WITH ART-123
•9. BODY WEIGHT ≥ 175 KG
•10. PT PROLONGATION OR THROMBOCYTOPENIA THAT IS NOT DUE TO SEPSIS (E.G. AML OR ALL IN INDUCTION THERAPY, ACUTE LEUKEMIA OF THE M3 TYPE, MYELOABLATIVE THERAPY WITHIN 4 WEEKS PRIOR TO ENROLLEMENT, AIDS WITH PERSISTENT THROMBOCYTOPENIA AND/OR BLEEDING DISORDER, PRE-EXISTING THROMBOCYTOPENIA OR COAGULOPATHY)

发起方

ASAHI KASEI PHARMA AMERICA CORPORATION,