A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
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: Treprostinil.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Arterial Hypertension. Базовые параметры: Без ограничений · 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
- Список центров уточняется — проверьте первичный протокол.
- 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 Multi-center, Prospective Study to Observe the Safety, Tolerability, and Efficacy of Remodulin® in Patients With Pulmonary Arterial Hypertension
Обзор
This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The objective in this study is to observe the efficacy and safety of treprostinil in subjects with pulmonary arterial hypertension.
Подробное описание
This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The expected study period will be 2 years. PAH patients, who met NHI criteria, to receive treprostinil subcutaneously/ intravenously, will be invited to join this study for observation. The dosage and administration schedule of study medication will be judged by investigators. If the eligibility criteria have been met and the subject have signed the informed consent, the subjects will be enrolled into this study. There will be 10 visits: Visit 1 (Screening visit, Week -2 \~ -1), Visit 2 (Week 1, initial of use treprostinil), Visit 3 to 9 (Week 13 to 85), Visit 10 (Week 97). The Day 1 in Week 1 should be the start day of treprostinil treatment. Subjects will be returned to the clinics every 3 months (i.e. 12 weeks) after Visit 2. The NT-proBNP level, WHO functional class, 6-minute walk distance, echocardiography, pulse oximetry, modified Borg Dyspnea Scale, SF-36 questionnaire, and dosage regimens of treprostinil (including dose adjustment) will be collected. For time to clinical worsening and death, it will be followed up during study period. All intercurrent events within 24 months will be recorded. Safety information, including vital signs, and physical exams will be checked. Adverse events of special interest (AESIs) will be reviewed every visit by using a predesignated AESI checklist.
Вмешательства
- Препарат Treprostinil
sc/iv continuously
Первичные конечные точки
- Change from baseline in NT-proBNP [Срок оценки: Week 97]
- Change from baseline in WHO functional class [Срок оценки: Week 97]
Вторичные конечные точки (12)
- Time to clinical worsening and death [Срок оценки: 96 weeks]
- Change from baseline in NT-proBNP [Срок оценки: Week 13, 25, 37, 49, 61, 73, and 85]
- Change from baseline in 6-minute walk distance (6MWD) [Срок оценки: Week 25, 49, 73, and 97]
- Trend of dose usage from initiation treatment to clinical worsening [Срок оценки: 96 weeks]
- Adverse events of special interest (AESIs) [Срок оценки: 96 weeks]
- Change from baseline in WHO functional class [Срок оценки: Week 13, 25, 37, 49, 61, 73, and 85]
- Change from baseline in right atrium (RA) area [Срок оценки: Week 25, 49, 73, and 97]
- Change from baseline in TAPSE/sPAP ratio. [Срок оценки: Week 25, 49, 73, and 97]
- Change from baseline in Pericardial effusion. [Срок оценки: Week 25, 49, 73, and 97]
- Change from baseline in modified Borg Dyspnea Scale [Срок оценки: Week 25, 49, 73, and 97]
- Change from baseline in SF-36 questionnaire [Срок оценки: Week 25, 49, 73, and 97]
- Intercurrent event [Срок оценки: 96 weeks]
Критерии участия
Критерии включения
- Diagnosed with symptomatic idiopathic or heritable PAH classified as WHO functional class III and IV symptoms.
- PAH patient, who met NHI criteria, will be scheduled to receive subcutaneous/intravenous treprostinil treatment.
- Ability to adhere to the study visit schedule and understand and comply with all protocol requirements.
- Will provide completed and signed written informed consents
Критерии исключения
- Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06603285 · EB057-PMS-01