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Clinical Trials List

Protocol NumberL606-301

NCT Number(ClinicalTrials.gov Identfier)NCT07285655

Not yet recruiting

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)

Trial Applicant

台灣喜帝諮詢顧問有限公司
Sponsor
Trial scale

Taiwan Multiple Center
Update

2026/04/08

Investigators and Locations

Principal Investigator Pin-Kuei Fu 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsao-Hsun Hsu 無

National Taiwan University Hospital

Co-Principal Investigator

郭耀文無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳懿哲無

MacKay Memorial Hospital

Co-Principal Investigator

吳書豪無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsin Hsu

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Hypertension Due to Lung Disease (Disorder)

Objectives

Primary Objective To evaluate the effect of inhaled L606 on changes in walking distance measured by the six-minute walk test (6MWT) in participants of the World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD). Key Secondary Objectives To evaluate the effects of inhaled L606 on the following: 1. Time to clinical worsening (TCW) 2. Six-minute walk distance (6MWD) at week 24 3. 6MWD at week 16

Test Drug

Inhalation suspensions

Active Ingredient

Treprostinil
Placebo

Dosage Form

106
106

Dosage

Multiple Dose/ Ampoule
Matching Multiple Dose/Ampoule

Endpoints

Changes in 6-minute walk distance (6MWD) from baseline to week 16.

Inclution Criteria

Inclusion 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.
EV1/FVC (ratio) > 0.70.
6-minute walk distance ≥ 150 meters

Exclusion Criteria

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

Taiwan

15 participants
Global

344 participants