A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations

Официальное название

A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications

Обзор

This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.

Вмешательства

• Препарат VI-0106
  Tacrolimus Extended-Release Capsules
• Препарат Placebo
  Inactive oral capsule

Первичные конечные точки

• Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24 [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (4)

• Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24 [Срок оценки: Baseline to Week 24]
• Time to clinical worsening defined as a composite of the following events: [Срок оценки: Baseline to Week 52]
• Time to clinical worsening by a restricted definition comprised of all-cause death and in-patient hospitalization for PAH or right-sided heart failure [Срок оценки: Baseline to Week 52]
• Change from baseline in 6MWD at Week 28 [Срок оценки: Baseline to Week 28]

Критерии участия

Критерии включения

• WHO Group 1 PH: Pulmonary Arterial Hypertension;
• WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;
• Right heart catheterization (RHC) at screening (or within 3 months prior to screening);
• Screening 6MWD >75 meters to ≤450 meters.

Критерии исключения

• PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
• Chronic thromboembolic or portopulmonary hypertension
• Total Lung Capacity (TLC) <60% predicted;
• FEV1/FVC <70% predicted or FEV1 <60% predicted;
• Evidence of left-sided heart disease;
• Inability to safely attempt completion of the 6MWD;
• Life expectancy <6 months;
• eGFR <30 mL/min/1.73 m2 (CKD-EPI equation);
• Moderate to severe hepatic dysfunction (Child-Pugh score >10);
• Serum potassium >5.1 mEq/L;
• Use of experimental PAH treatments within the past 3 months;
• Active infection requiring antibiotic, antifungal, or antiviral therapies;
• Current systemic treatment with cyclosporine;
• Known allergy or hypersensitivity to tacrolimus;
• Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07612657 · PH-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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