EUCTR2007-002035-81-GB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
适应症
试验速览
- 阶段
- 1 期
- 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
入选标准
- •Candidates for this study must meet ALL of the
- •following criteria:
- •1. Bacterial infection or suspected bacterial infection and being treated with antimicrobial medication(s).
- •2. DIC score of =2 using a modified ISTH algorithm
- •3. Subject presents with >2 of the following sepsis related SIRS criteria within the 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 can not 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 subject
- •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. DIC not due to sepsis (see protocol for further details)
- •11. Intra-thoracic, intra-abdominal, or intra-cranial surgery, within the previous 12 hours to enrollment, 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 an increased risk for developing hemorrhagic pancreatitis over the duration of the study.
- •22. Severe renal failure characterized
研究者
相似试验
进行中（未招募）
1 期
Myelofibrosis: Phase 3 Study of Navitoclax Plus Ruxolitinib Versus RuxolitinibMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MyelofibrosisEUCTR2020-000097-15-SEAbbVie Deutschland GmbH & Co. KG230
进行中（未招募）
1 期
A study of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Soft Tissue SarcomaAdvanced or Metastatic Soft Tissue SarcomaMedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 100000004864EUCTR2015-000134-30-PLEli Lilly and Company460
进行中（未招募）
1 期
Myelofibrosis: Phase 3 Study of Navitoclax Plus Ruxolitinib Versus RuxolitinibMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MyelofibrosisEUCTR2020-000097-15-BEAbbVie Deutschland GmbH & Co. KG230
进行中（未招募）
1 期
A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus ErythematosusMedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersSystemic Lupus ErythematosusEUCTR2019-003323-38-DEEli Lilly & Company280
进行中（未招募）
1 期
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.Hereditary Angioedema Type I or IIMedDRA version: 21.0Level: LLTClassification code 10080956Term: Hereditary angioedema type ISystem Organ Class: 100000004850MedDRA version: 24.0Level: LLTClassification code 10080960Term: Hereditary angioedema type IISystem Organ Class: 100000004850EUCTR2021-000136-59-BGKalvista Pharmaceuticals Ltd48