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临床试验/NCT05572996
NCT05572996Available不适用

Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease

Ferrer Internacional S.A.0 个研究点开始时间: 2022年10月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Available

研究概览

简要总结

This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consent
  • Males and females aged 18 years old or older
  • PH-ILD diagnosis:
  • Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC):
  • mPAP > 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and
  • Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE)

排除标准

  • Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
  • Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
  • Use of any concomitant investigational drug

研究者

申办方类型
Industry
责任方
Sponsor

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