JPRN-jRCT2080220566未知3 期
A randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis Induced Cardiovascular and Respiratory Failure
试验速览
- 阶段
- 3 期
- 入组人数
- 2,500
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 ot applicable（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria
- •1. Subject is aged 18 years or older, with bacterial or infection for which he/she is receiving parenteral antimicrobial therapy.
- •2. Subject has septic shock diagnosed and developed respiratory failure within 36 hours prior to study drug administration, and meets at least 3 of the 4 SIRS criteria.
- •Main Exclusion Criteria
- •1. Subject is known to be immunocompromised, and is currently receiving immunosuppressive therapy or a cancer related chemotherapeutic agent.
- •2. Prior to the onset of sepsis, the subject would not otherwise have been expected to survive 28 days or to complete a functional recovery due to a pre-existing unstable medical condition.
- •3. Subject has acute third degree burns involving more than 30% of body surface area.
- •4. Subject, family, or physician is not committed to full aggressive management.
- •5. Subject has known hypersensitivity to sulphonamides, or is allergic to eggs, egg products or soybeans.
- •6. Subject has a documented history of chronic heart failure as defined by NYHA functional classification III or IV.
- •7. Subject has severe end stage chronic respiratory failure or chronic end stage hepatic failure.
排除标准
- 未提供
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia (CAH)MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000004850EUCTR2019-004873-17-DEeurocrine Biosciences, Inc.165
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720
已完成
不适用
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109abdominal pain and heartburn10017943NL-OMON30044Janssen-Cilag82