JPRN-UMIN000032531已完成2 期
Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension - Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertension
Japan Agency for Medical Research and Development (AMED)0 个研究点目标入组 12 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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) Patients with malignancy or undergone surgeries due to malignancy within 5 years. 2) Patients taking statins and can NOT stop them from 3 days before administration of NK-104-NP. 3) Patients taking fibrates and can NOT stop them from 3 days before administration of NK-104-NP. 4) Patients taking cyclosporine. 5) Patients with severe cardiac dysfunction or heart failure (<30% ejection fraction or NYHA class III or over). 6) Patients with untreated severe arrhythmia except symptomatically stable patients with pacemaker or drug therapy. 7) Patients after prosthetic valve replacement (except biomaterials). 8) Patients with acute hepatitis, fulminant hepatitis or progressive liver dysfunction. 9) Patients with moderate or severe liver dysfunction (who can NOT satisfy following criteria) associated with chronic hepatitis etc. except patients with liver cirrhosis. a) AST/ALT is within 3 times upper limit of shared reference range, b) serum bilirubin is 2 times upper limit of shared reference range. 10) Patients with liver cirrhosis and Child B(moderate) or C(severe) liver dysfunction. 11) Patients with obvious interstitial pneumonia. 12) Patients with biliary atresia. 13) Patients with CK(CPK) elevation over 3 times upper limit of shared reference range. 14) Patients with past-history of hypersensitivity or severe adverse effects by pitavastatin calcium. 15) Patients with severe drug allergy or adverse effects including anaphylactic shock. 16) Patients with alcohol abuse or drug addiction. 17) Patients in other trials at the time of informed consent or patients less than 16 weeks after termination of other test drugs. 18) Patients with pregnancy, patients with a possibility of pregnancy and breast-feeding women. 19) Patients judged to be inappropriate as a candidate of this trial by principal investigator or subinvestigator.
研究者
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