Clinical Trials List
2025-12-28 - 2031-12-31
Phase III
Recruiting5
ICD-10I27.0
Primary pulmonary hypertension
ICD-9416.0
Primary pulmonary hypertension
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (WHO Group 3)
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Trial Applicant
台灣喜帝諮詢顧問有限公司
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/08/06
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭耀文 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Placebo
Dosage Form
106
Dosage
Matching Multiple Dose/Ampoule
Endpoints
Inclution Criteria
Participant is between 18 years to 80 years old.
Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.
Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:
Pulmonary vascular resistance (PVR) ≥ 320 dynes.sec/cm5 (i.e. 4 Woods Units (WU)), and
Mean Pulmonary Artery Pressure (mPAP) of ≥ 25 mmHg, and
- Pulmonary capillary wedge pressure (PCWP) or Left-Ventricular End Diastolic Pressure (LVEDP) of ≤ 15 mmHg.
FEV1/FVC (ratio) > 0.70.
6-minute walk distance ≥ 150 meters
Exclusion Criteria
PH in the updated WHO Classification Groups 1, 2, 4, or 5.
Has evidence of clinically significant left-sided heart disease as defined by echocardiography.
Participants with history of persistent/permanent or uncontrolled atrial fibrillation.
Participants with severe obstructive sleep apnea.
Has experienced exacerbation of underlying lung disease or active respiratory infection requiring antibiotics.
Initiation of pulmonary rehabilitation.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
344 participants
