JPRN-UMIN000009572已完成未知
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis - Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis
TT Bio-Pharma Co., Ltd.0 个研究点目标入组 96 人开始时间: 2012年12月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 96
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Exclusion criteria involving similar diseases (1)Patients who's IPF was clearly caused by pharmaceuticals (2)Patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD) FEV1% <70% or Patients who are diagnosed with severe COPD from the HRCT image (3)Patients diagnosed with a pulmonary or respiratory infection that may affect the efficacy of the study drug 2) Exclusion criteria due to previous treatment (1)Patients who started to use steroids or changed the dose of the steroid within 4 weeks prior to the study drug administration. (2)Patients who used immunosuppressants , pirfenidone, N-acetylcysteine or steroids within 4 weeks prior to study drug administration (on the other hand, those who stop these drugs for any reason and have a washout period of >=4 weeks can be enrolled). 3) Exclusion criteria due to potential safety issues (1)Patients having Grade 4 hepatic, renal, or digestive disorders (2)Patients who have complicated ≥ Grade 4 hematologic disorders or cardiovascular diseases (3)Patients who have complicated malignant neoplasm such as cancer or tumor occurring within 5 years before enrollment, however, patients with a history of lung cancer cannot enroll. (4)Patients who are pregnant or possibly pregnant, or nursing (5)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug (6)Patients who have a drug dependency or a history of drug abuse (7)Patients who are current smokers (8)Patients are sensitive to any drugs (all drugs prescribed or commercially available drugs) or have history of sensitivity to the drugs (9)Patients who have taken PC-SOD or PC-SOD NE previously in their medical history (10) Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators.
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