A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

未提供0 个研究点目标入组 344 人开始时间: 待定

适应症

试验速览

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•Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
•Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
•Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 (NCT07234032) study.

•Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
•Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
•Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).
•Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.
•Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).

发起方

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