NL-OMON54466尚未招募2 期
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible, a participant is required to be or have:
- •1• Male or female adults between 18 and 75 years of age at the screening visit
- •within 28 days
- •prior to Day 1.
- •2• Subject with a diagnosis of PAH belong to one of the subgroups of the NICE
- •classification of
- •a. I/HPAH, PAH-CTD,
- •b. PAH due to drugs and toxins (having been in the care of the
- •investigator for
- •at least one year with no relapses of drug or toxin/chemical
- •c. HIV associated or
- •d. PAH due to repaired congenital heart disease (at least 1 year since
- •*Excluding patients with Portopulmonary Hypertension.
- •3• World Health Organization (WHO) Functional Class II, III or IV symptoms
- •4• Meets all of the following hemodynamic criteria by means of an RHC at study
- •Screening: mPAP
- •>= 25 mmHg, PVR > 400 dynes.sec/cm5 and PCWP <= 15 mmHg.
- •* For the Phase 2b part: subjects who have had an RHC within 30 days of
- •the Screening visit
- •to assess for pulmonary hypertension, with all the protocol required
- •variables collected, and
- •was performed at the same institution as the Investigator*s site do
- •not require the
- •Screening/Baseline RHC to be performed.
- •* For the Intermediate and Phase 3 Parts: RHC procedures performed
- •within 12-months of
- •screening may be accepted provided the subject meets the Inclusion
- •Criteria #5
- •requirements for stable background PAH medication.
- •5• On a stable background of at least two PAH approved medications at the
- •Screening Visit,
- •i.e., the same PAH medications for at least 90 days and each PAH
- •medication at a stable
- •dose for at least 30 days. Approved PAH medications include
- •phosphodiesterase type 5
- •(PDE-5) inhibitors, endothelin receptor antagonists (ERA), soluble
- •guanylate cyclase
- •(sGC) stimulators, and parenteral and oral prostacyclins (including
- •prostanoids and prostacyclin
- •receptor agonists). Stability of parenteral prostacyclins means a change
- •of no more than 10% in
- •the previous 30 days from the Screening Visit.
- •6• A history of ventilation/perfusion (V/Q) scan, CT angiogram or pulmonary
- •arteriogram negative
- •for chronic thromboembolic pulmonary hypertension (CTEPH) at the time
- •of their Group 1 PAH
- •diagnosis (if results from a historical scan are unavailable then one
- •of the specified imaging
- •procedures may be performed at Screening).
- •7• Must meet all of the following criteria for pulmonary function (spirometry)
- 另有 17 项未显示
排除标准
- •1• Taking warfarin (or any vitamin K antagonists), direct oral anticoagulant
- •(DOAC) therapy, or
- •dual antiplatelet therapy within 2 weeks prior to Day 1/Randomization
- •2• Pulmonary hypertension (PH) belonging to Groups 2 to 5 of the 2018 NICE
- •classification and
- •Group 1 diagnosed with Portopulmonary Hypertension.
- •3• History of left ventricular ejection fraction (LVEF) <= 40% on echocardiogram
- •within 12 months
- •of screening, or clinically significant ischemic, mitral or aortic
- •valve disease, or constrictive
- •heart disease in the opinion of the Investigator.
- •4• Evidence of three or more (>= 3) of the following left ventricular
- •disease/dysfunction risk factors:
- •o Body mass index (BMI) >= 30 kg/m2 at the Screening Visit
- •o History of essential hypertension
- •o Diabetes mellitus - any type
- •o Historical evidence of significant coronary artery disease (CAD)
- •established by any one of
- •the following:
- •- History of myocardial infarction
- •- History of percutaneous coronary intervention (PCI)
- •- Angiographic evidence of CAD (> 50% stenosis in at least one
- •vessel), by
- •angiography
- •- Positive stress test with imaging
- •- Previous coronary artery surgery
- •- History of chronic stable angina or unstable angina
- •5• Taking inhaled prostacyclins within the past 3 months prior to the Screening
- •6• History of chronic uncontrolled asthma (subjects on corticosteroids will be
- •allowed into the
- •7• History of any illness or condition that, in the opinion of the Investigator
- •could confound
- •the results of the study or pose an additional risk to the subject
- •through their participation
- •in the study
- •8• Inability to use or may have potential difficulties using an inhaler device
- •during each dosing
- •9• Participating in a clinical study (e.g., attending follow-up visits) or who
- •have received an
- •investigational drug (new chemical entity) in the past 30 days prior to
- •the Screening Visit.
- •Involvement in strictly observational studies (Registries) is allowed
- •provided this is
- •approved by the Contract Research Organization (CRO) Medical Monitor.
- •10• Donated blood, plasma, or platelets in the month prior to screening or who
- •donations on more than two occasions within the 12 months preceding the
- •administration of study drug or have had a loss of >= 400 mL of blood
- •within 2 months prior
- •to Day 1/Randomization
- •11• Deficient thrombocyte function, Thrombocytopenia < 50 x10^9/L (50 x
- 另有 17 项未显示
研究者
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