NCT02739165已完成3 期
Phase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Survival rate on Day 90
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with IPF who meet all criteria from (1) through (4) during the course of IPF
- •(1)Unexplained development or worsening of dyspnea within 1 month during the course of IPF
- •(2)Finding of new, bilateral ground glass opacities and/or consolidation on HRCT
- •(3)No apparent Pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure
- •(4)A decrease* in PaO2 of ≥10 mmHg or SpO2 of ≥4% under the same conditions compared with the level at the previous measurements
- •(*) In cases where no PaO2 or SpO2 test values under the same conditions are available, a patient with a P/F ratio ≤300 in the current episode of acute exacerbation is considered to have met criterion (4)
- •Aged 40 years or older and no older than 85 years at the time of informed consent with either sex
排除标准
- •Have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage)
- •Have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent
- •Patients for whom the completion of hemostatic treatment has not been confirmed after undergoing surgery of the central nervous system or after trauma
- •Have a high risk for fatal or life-threatening hemorrhage
- •Patients with malignant tumors
- •Have acute exacerbation attributable to drug induced pulmonary disorder, after surgery for malignant tumors, chemotherapy, or radiation therapy
- •Have acute exacerbation due to a thoracic surgical procedure (including thoracoscopic lung biopsy)
- •Have a history of acute exacerbation of IPF
- •Receiving mechanical ventilation through intratracheal intubation
- •Patients who are pregnant or nursing, or who may be pregnant
- •Patients with a platelet count less than 100,000/uL at the time of enrollment
- •Patients with severe renal (serum Cr: ≥4 mg/dL) or hepatic (AST/ALT: ≥500 IU/L or T-Bil: ≥10 mg/dL) dysfunction
- •Have been administered a commercially available thrombomodulin alfa (recombinant )(Recomodulin® for Intravenous Injection 12800) within 30 days before the start of investigational product administration
- •Have a history of hypersensitivity for investigational product
研究组 & 干预措施
ART-123
Experimental
干预措施: ART-123 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Survival rate on Day 90
时间窗: 90 days
次要结局
- Overall survival(180 days after the start of investigational product administration in the last subject)
- Survival time up to Day 90(90days)
- P/F ratio(4 days, 7 days, 15 days, 28 days, 60 days, 90 days)
- Coagulation tests(4 days, 7 days, 15days, 28 days, 60 days, 90 days)
研究者
相似试验
已完成
3 期
Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosisAcute exacerbation of idiopathic pulmonary fibrosis (AE-IPF)JPRN-jRCT2080223271ASAHI KASEI PHARMA CORPORATIO74
已完成
2 期
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon CancerPostoperative Stage II/III Colon CancerNCT02792842Asahi Kasei Pharma Corporation79
撤回
3 期
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic StrokeIschemic StrokeNCT05484154ZZ Biotech, LLC1,400
终止
3 期
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic HyponatremiaHyponatremiaNCT01451411Cumberland Pharmaceuticals4
进行中（未招募）
2 期
Safety, Pharmacokinetics and Efficacy of an ATIII ConcentrateAntithrombin III DeficiencyNCT00319228Grifols Biologicals, LLC30