A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Wean Success vs Wean Failure
研究概览
简要总结
The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo an attempt to wean from parenteral PGI per standard of care.
详细描述
This study will be divided into 2 parts: a Pilot Phase followed by Pivotal Phase.
- The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot Phase will evaluate safety, and assess the vasoreactivity test response rate.
- Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to gather further data on weaned successes from parenteral PGI. The Investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or subject's legally authorized representative signs and dates an Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study-related activities.
- •The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I or II at Screening.
- •The subject has documented continuous PGI use for ≥ 1 year from Screening, without a significant interruption (i.e., ≤ 2 day interruption) and without a failed complete wean attempt.
- •The subject is a candidate for weaning off parenteral PGI therapy (per Investigator judgment and standard of care).
- •Exclusion Criteria
- •The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide or other clinically significant allergies (clinical significance per Investigator judgment).
- •The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at Baseline.
- •The subject has participated in an investigational product or device study within the 30 days prior to Screening.
排除标准
- 未提供
研究组 & 干预措施
Inhaled Nitric Oxide
Active Comparator: Nitric Oxide
干预措施: Inhaled Nitric Oxide (Drug)
结局指标
主要结局
Wean Success vs Wean Failure
时间窗: Visit 4 - Day 84
To evaluate the number of subjects that achieve Wean Success that are Vasoreactivity Response (VR) positive (+) versus VR negative (-)and the number of subjects that are Wean Failures that are VR(+) versus VR(-). Wean-Success: * No parenteral PGI therapy at 3 months post-wean completion; and * Clinical stability, where clinical stability is defined as: * A decrease in 6MWT distance less than 10% from pre-wean; and * NT-proBNP increase \<15% from pre-wean; and * WHO Functional Class \<III Wean-Failure: * Subjects that wean successfully but do not meet all clinical stability components of the Wean-Success definition above; or * Failure to wean within the 3 month Transition Period; or * Re-initiation of parental PGI during the 3 month post-wean or subject does not meet the definition of clinical stability at 3 month post-wean; or * Death or hospitalization due to progression of disease; or * Atrial septostomy; or * Heart and/or lung transplantation
次要结局
未报告次要终点