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Набира участници Фаза 3 NCT07179380

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Pulmonary Hypertension Interstitial Lung Disease

Спонсор: Insmed Incorporated

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
Кой може да участва
Inclusion Criteria * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months. * PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings: * Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and * Pulmonary vascular resistance (PVR) ≥4 wood units (WU). * 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%. * Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening. * Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion criteria * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease. * Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months). * Clinically significant left heart disease: * evidence of clinically significant left-sided valvular heart disease, * left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF) * echocardiography findings at Screening suggestive for postcapillary PH * unstable ischemic heart disease * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed) * 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). * Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days. * Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study. * 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. Note: Other protocol defined inclusion/exclusion criteria may apply.
Места на провеждане 20
Argentina (1)
ARG002
CiudadAutonoma de Buenos Aires , Buenos Aires
NOT_YET_RECRUITING
Австралия (1)
AUS003
Westmead , New South Wales
NOT_YET_RECRUITING
Белгия (1)
BEL002
Leuven
ACTIVE_NOT_RECRUITING
Чехия (1)
CZE001
Prague
Дания (1)
DNK001
Aarhus N , Central Jutland
NOT_YET_RECRUITING
Франция (1)
FRA009
Nice , Alpes-Maritimes
NOT_YET_RECRUITING
Georgia (1)
GEO002
Tbilisi
ACTIVE_NOT_RECRUITING
Гърция (1)
GRC003
Pátrai , Achaia
NOT_YET_RECRUITING
Израел (1)
ISR003
Petah Tikva , Central District
ACTIVE_NOT_RECRUITING
Италия (1)
ITA012
Sassari
ACTIVE_NOT_RECRUITING
Япония (1)
JPN006
Nagakute , Aichi-ken
ACTIVE_NOT_RECRUITING
New Zealand (1)
NZL001
Christchurch , Canterbury
ACTIVE_NOT_RECRUITING
Португалия (1)
PRT001
Lisbon
ACTIVE_NOT_RECRUITING
Румъния (1)
ROU002
Târgu Mureş , Mureș County
NOT_YET_RECRUITING
Южна Корея (1)
KOR002
Incheon
NOT_YET_RECRUITING
Испания (1)
ESP002
Palma de Mallorca , Balearic Islands
Швейцария (1)
CHE001
Basel
NOT_YET_RECRUITING
Taiwan (1)
TWN001
Kaohsiung City
ACTIVE_NOT_RECRUITING
Великобритания (1)
GBR004
Yorkshire , United Kingdom
NOT_YET_RECRUITING
САЩ (1)
USA010
Los Angeles , California
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.01.2026
Крайна дата
30.12.2028
Регистрационен номер
NCT07179380
Източник
anzctr
Запитване за медицински туризъм

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