NCT07612657尚未招募3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- VIVUS LLC
- 入组人数
- 300
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究者
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