Clinical Trials List
Protocol NumberINS1009-301
NCT Number(ClinicalTrials.gov Identfier)NCT07481981
Not yet recruiting
2026-04-24 - 2029-07-31
Phase III
Recruiting3
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- 吳書豪 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- 張皓智 Division of Cardiovascular Diseases
- Kang-Ling Wang 臨床試驗科
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chih-Hsin Hsu
Co-Principal Investigator
- 林佳淩 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pulmonary Arterial Hypertension
Objectives
期試驗將進一步評估 TPIP 用於更大範圍的 PAH 受試者群體之療效、安全性和耐受性。
Test Drug
吸入用膠囊劑
Active Ingredient
Treprostinil palmitil
Dosage Form
430
Dosage
80 μg, 160 μg, 320 μg, 640 μg
Endpoints
第 24 週時，給藥後 1 至 3 小時測得的 6MWD 相較於基準期之變化
第 24 週時，WHO 功能分級相較於基準期有所改善的受試者比例
第 22 週時，在前一劑給藥後 24 小時 (±2) 測得的 6MWD 相較於基準期之變化
第 24 週時，NT-proBNP 濃度相較於基準期之變化
第 24 週時，PAH-SYMPACT 問卷中「身體影響」範疇分數相較於基準期之變化
第 24 週時，PAH-SYMPACT 問卷中「心肺症狀」範疇分數相較於基準期之變化
自基準期至第 24 週，出現首次臨床惡化事件的經過時間：
•任何原因的死亡
•因 PAH 惡化而住院（≥24 小時）
•需要進行心房中膈造口術
•因惡化而列入肺部或心肺移植等候名單
•需要開始使用核准的 PAH 療法（例如 IV epoprostenol、IV 或皮下注射 treprostinil）來進行非腸道療法
•PAH 惡化，定義為由研究疾病所致而同時出現下列相較於基準期的變化：
○6MWD 減少 ≥ 15%，並需透過間隔至少 4 小時但不超過 2 週的兩次檢測加以確認，且
○出現右心衰竭惡化的徵象／症狀或 NYHA/WHO 功能分級惡化。
所有事件將由盲性獨立臨床專家委員會判定。
第 24 週時，WHO 功能分級相較於基準期有所改善的受試者比例
第 22 週時，在前一劑給藥後 24 小時 (±2) 測得的 6MWD 相較於基準期之變化
第 24 週時，NT-proBNP 濃度相較於基準期之變化
第 24 週時，PAH-SYMPACT 問卷中「身體影響」範疇分數相較於基準期之變化
第 24 週時，PAH-SYMPACT 問卷中「心肺症狀」範疇分數相較於基準期之變化
自基準期至第 24 週，出現首次臨床惡化事件的經過時間：
•任何原因的死亡
•因 PAH 惡化而住院（≥24 小時）
•需要進行心房中膈造口術
•因惡化而列入肺部或心肺移植等候名單
•需要開始使用核准的 PAH 療法（例如 IV epoprostenol、IV 或皮下注射 treprostinil）來進行非腸道療法
•PAH 惡化，定義為由研究疾病所致而同時出現下列相較於基準期的變化：
○6MWD 減少 ≥ 15%，並需透過間隔至少 4 小時但不超過 2 週的兩次檢測加以確認，且
○出現右心衰竭惡化的徵象／症狀或 NYHA/WHO 功能分級惡化。
所有事件將由盲性獨立臨床專家委員會判定。
Inclution Criteria
Inclusion Criteria
Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
Connective tissue disease (CTD)-associated PAH
PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
PAH diagnosis for at least 3 months prior to Screening.
New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose
Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose
Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose
Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:
no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.
no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.
platelet counts ≥100,000 per microlitre (μL) at Screening
For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.
Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria:
Mean pulmonary arterial pressure (PAP) >20 millimetre of mercury (mmHg) at rest.
pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.
pulmonary vascular resistance (PVR) of ≥5 wood units (WU).
Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
Connective tissue disease (CTD)-associated PAH
PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.
PAH diagnosis for at least 3 months prior to Screening.
New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.
Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:
Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose
Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose
Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose
Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:
no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.
no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.
platelet counts ≥100,000 per microlitre (μL) at Screening
For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.
Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria:
Mean pulmonary arterial pressure (PAP) >20 millimetre of mercury (mmHg) at rest.
pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.
pulmonary vascular resistance (PVR) of ≥5 wood units (WU).
Exclusion Criteria
Exclusion Criteria
Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).
Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.
Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) <0.7.
Evidence of significant restrictive lung disease as evidenced by FVC <70% predicted normal.
Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).
Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.
Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) <0.7.
Evidence of significant restrictive lung disease as evidenced by FVC <70% predicted normal.
Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).
Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
344 participants
