A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: L606, Placebo.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Hypertension Due to Lung Disease (Disorder). Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австрия, Бельгия, Франция, Германия +4
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.
Вмешательства
- Препарат L606
L606 is a liposomal version of treprostinil intended for delivery via oral inhalation using a study issued nebulizer. - Препарат Placebo
Placebo will match L606 but contain no treprostinil.
Первичные конечные точки
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Срок оценки: 16 weeks]
Вторичные конечные точки (3)
- Time to first occurrence of: -Death -Hospitalization due to a cardio-pulmonary indication related to underlying disease -Lung transplant -Decrease in 6MWD > 15% from Baseline related to disease under study at 2 consecutive visits >1 week apart [Срок оценки: 24 weeks]
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Срок оценки: 16 weeks]
- Change from baseline in 6-minute walk distance (6MWD) as evaluated by the 6-minute walk test (6MWT) [Срок оценки: 24 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Note: Other protocol defined inclusion/exclusion criteria may apply.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 5 центров
- Arizona Pulmonary Specialists, Ltd. — Scottsdale
- Tampa General Hospital — Tampa
- Northwestern University — Chicago
- St. Vincent Cardiovascular Research Institute — Indianapolis
- Summit Health — Bend
Германия · 3 центра
- Universitätsklinikum Giessen und Marburg - Standort Giessen — Giessen
- University Medical Center Hamburg-Eppendorf — Hamburg
- Medizinische Hochschule Hannover — Hanover
Великобритания · 2 центра
- Royal United Hospitals Bath NHS Foundation Trust — Bath
- University Hospitals Plymouth NHS Trust - Derriford Hospital — Plymouth
Австрия · 1 центр
- Ordensklinikum Linz GmbH — Linz
Бельгия · 1 центр
- Universitair Ziekenhuis Gent — Ghent
Франция · 1 центр
- Assistance Publique Hopitaux De Paris — Le Kremlin-Bicêtre
Латвия · 1 центр
- Pauls Stradinš Clinical University Hospital — Riga
Португалия · 1 центр
- Unidade Local De Saude De Almada-Seixal E.P.E. — Almada
Испания · 1 центр
- Hospital Del Mar — Barcelona
Идентификаторы
NCT: NCT07285655 · L606-301