EUCTR2021-003273-66-ES进行中（未招募）1 期
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •1. Suspected, presumed or documented community-acquired pneumonia by imaging.
- •2. Meets Sepsis 3 criteria: the presence of organ dysfunction as identified by a total SOFA score =2 points above pre-admission SOFA.
- •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 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •1. Invasive ventilated patient and PaO2/FiO2 < 100 mmHg
- •2. SOFA score = 10 at screening (Day -1).
- •3. Patients with septic shock; requiring persisting hypotension treated with vasopressors to maintain MAP =65 mmHg AND having a serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation at screening and on Day 1 prior to IP administration
- •4. Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or chronic viral infections, such as, hepatitis B virus (HBV) or hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other chronic infections.
- •5. Chronic respiratory disease requiring home oxygen therapy on a regular basis for > 6 h/day.
研究者
相似试验
撤回
2 期
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients1. Sepsis2. A life-threateningmedical emergency caused by an infection in the blood stream that can affect different organs10019815NL-OMON53483Enlivex Therapeutics R&D Ltd;7
进行中（未招募）
1 期
Phase 2 study to evaluate efficacy and safety of Allocetra-OTS in patients with sepsisMedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsSepsisEUCTR2021-003273-66-NLEnlivex Therapeutics R&D Ltd.160
招募中
1 期
Phase 2 study, conducted in few medical centers, patients will be allocated randomly to receive active drug or placebo. The study will evaluate the efficacy and safety of different doses of the drug in patients with organ failure due to sepsis condition.SepsisEUCTR2021-003273-66-ITEnlivex Therapeutics R&D Ltd.160
进行中（未招募）
1 期
A multi-center clinical study with LJPC-401 for the treatment of iron overload in adult patients with hereditary hemochromatosisHereditary HemochromatosisMedDRA version: 20.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2017-003598-33-GBa Jolla Pharmaceutical Company76
进行中（未招募）
1 期
A Study to Evaluate the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7204239 in Participants with Facioscapulohumeral Muscular DystrophyFacioscapulohumeral muscular dystrophy (FSHD)MedDRA version: 20.0Level: PTClassification code: 10064087Term: Facioscapulohumeral muscular dystrophy Class: 100000004850CTIS2022-503117-36-00F. Hoffmann-La Roche AG48