JPRN-jRCT2051230173招募中2 期
Single center, open-label Phase-IIa trial of tocilizumab in patients with sepsis or septic shock
Jun Oda0 个研究点目标入组 60 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1) Patients who have obtained consent for participation in the clinical trial from the patient or the patient's surrogate through the consent document
- •2) Japanese patients who are at least 18 years old and less than 85 years old at the time of consent
- •3) Patients diagnosed with sepsis or septic shock based on Sepsis-3
- •4) Patients with infection or suspected infection in the lungs, abdomen, urinary tract, etc.
- •5) Patients with acute organ failure within 48 hours of ICU admission
- •6) Patients with lactate levels greater than 2 mmol/L (18 mg/dL) at screening
- •7) Patients with blood IL-6 level >100 pg/mL at screening
排除标准
- •1) Patients who are judged by the investigator (subinvestigator) to die within 48 hours with or without treatment.
- •2) Patients with organic brain disorder.
- •3) Patients with cardiopulmonary arrest before admission to the ICU.
- •4) Patients chronically receiving dialysis.
- •5) Patients with uncontrolled coagulopathy requiring blood transfusion or with active bleeding.
- •6) Patients with shock for reasons other than sepsis.
- •7) Patients requiring surgical drainage. However, catheter drainage is acceptable.
- •8) Patients with no intention to prolong life or resuscitation.
- •9) Patients who have suffered serious trauma or burns within 36 hours prior to ICU admission.
- •10) Patients with soft tissue skin infections.
- •11) Patients who require laparotomy during the study period or who have undergone laparotomy,craniotomy,or thoracotomy within 24 hours prior to ICU admission.
- •12) Patients with active carcinoma requiring active treatment such as surgery,radiotherapy,or anticancer therapy.
- •13) Patients with a history of severe allergic reaction to tocilizumab or other monoclonal antibodies.
- •14)Patients with active tuberculosis infection at the time of enrollment.
- •15) Patients with chronic hepatitis B or C at the time of enrollment.
- •16) Patients who have received drug therapy (oral or immunomodulatory) for rejection in the 3 months prior to enrollment.
- •17) Patients who received anti-IL-6 therapy (including tocilizumab) in the 3 months prior to enrollment.
- •18) Patients with ALT or AST greater than 10 times the upper reference limit at screening.
- •19) Patients with hepatic encephalopathy.
- •20) Patients who meet the following laboratory criteria at screening.
- •Platelet count < 5 x10^4 /uL
- •White blood cell count less than 3500/uL
- •Neutrophil count less than 1000/uL
- •Lymphocyte count less than 500/uL
- •21) Patients with COVID-19 infection.
- •22) Patients who have been previously enrolled in this study and have received an investigational drug.
- •23) Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test on screening.
- •24) Patients who have received a live vaccine or attenuated live vaccine within 4 weeks prior to screening.
- •25) Patients who received any other investigational drug within 30 days prior to enrollment or within 5 times the half-life of the other investigational drug, whichever is longer.
- •26) Patients who are judged by the investigator (subinvestigator) to be incompetent to comply with the study protocol.
- •27) Patients who are judged by the investigator to be incapable of abstinence or contraception for a certain period of time. In addition, male patients who are judged by the investigator to be unable to abstain from sperm donation during the same period.
- •28) Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in the clinical trial for any reason.
研究者
相似试验
撤回
2 期
Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 13 substudy 31: EntrectinibCancer - Lung - Non small cellCancer - Any cancerCancerACTRN12621000284864The University of Sydney16
已完成
不适用
An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerancefamilial Mediterranean feverJPRN-UMIN000032557Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences24
进行中（未招募）
1 期
A MULTICENTER TRIAL OF A NEW CUSTOMIZED DOSING (RATIONAL ADJUSTMENT OF DOSE TO REDUCE ADVERSE REACTIONS RADAR” DOSING) OF NIRAPARIB AS MAINTENANCE THERAPY IN PLATINUM SENSITIVE OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL RECURRENT CANCER PATIENTSOvarian, fallopian tube or primary peritoneal recurrent cancerMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10038604Term: Reproductive system and breast disordersSystem Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-003736-77-DEIstituto di Ricerche Farmacologiche Mario Negri IRCCS105
未知
2 期
A phase II study, multicenter, open label trial of R1415 (erlotinib hydrochloride) in patients with advanced/metastatic or recurrent non-small cell lung cancer. (JO18396)Advanced or metastatic or recurrent non-small cell lung cancerJPRN-jRCT2080220075Chugai Pharmaceutical Co., Ltd.
进行中（未招募）
不适用
Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment.Perianal fistulas in Crohn's Disease PatientsMedDRA version: 14.1Level: PTClassification code 10002156Term: Anal fistulaSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-006127-38-ESFundación FISEVI