EUCTR2012-000166-37-PL进行中（未招募）不适用
A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-mandated procedures.
- •2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Has a current diagnosis of symptomatic PAH classified by one of the following:
- •a. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH); or
- •b. PAH associated with one of the following CTD:
- •i. Systemic sclerosis (scleroderma);
- •ii. Limited scleroderma;
- •iii. Mixed connective tissue disease;
- •iv. Systemic lupus erythematosus;
- •v. Overlap syndrome.
- •c. PAH associated with:
- •i. HIV infection;
- •ii. Simple, congenital systemic-to-pulmonary shunts at least one year post surgical repair.
- •iii. Exposure to legal drugs, chemicals and toxins, such as fenfluramine derivatives, other anorexigens, toxic rapeseed oil or L-tryptophan. Subjects with PAH associated with illegal drug use, such as methamphetamine, are excluded.
- •4. Has a cardiac catheterization prior to Screening that is consistent with the diagnosis of PAH meeting all of the following criteria:
- •a. mPAP = 25 mmHg (at rest);
- •b. PCWP = 15 mmHg; and
- •c. If PCWP is not available, then mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) = 15 mmHg in the absence of left atrial obstruction;
- •c. PVR > 3 mmHg/Liter (L)/minute (min) or 240 dyn.sec/cm.
- •5. A qualification cardiac catheterization is required, to confirm the persistence and severity of PAH, if the diagnostic catheterization was performed more than 1 month (30 days) prior to Baseline/Day 1 (see criteria in Inclusion Criteria #4). This catheterization will serve to
- •provide Baseline hemodynamic values for further efficacy analysis. A cardiac catheterization performed within 1 month (30 days) prior to Baseline/Day 1, per the subject standard medical care (not for the purposes of this study) can be used in lieu of repeating the test, if all
- •the following criteria are met:
- •a. Confirms diagnosis as per the required data points (PVR, CO, CI, mPAP, mRAP, PCWP, SVR, and SvO 2 );
- •b. The subject has a PVR above 300 dyn.sec/cm on the catheterization used to qualify the subject for the study; and
- •c. No change in disease-specific PAH therapy has occurred since the catheterization used to qualify the subject for the study.
- •6. Newly diagnosed PAH on no disease-specific PAH therapy or previously diagnosed with PAH on stable (i.e. 3 months (90 days) prior to the Baseline qualification cardiac catheterization) oral disease-specific PAH therapy with either an ETRA and/or PDE-5i. Every attempt should be made to maintain the dose of these agents throughout the study. The use of PDE-5i as needed for erectile dysfunction (ED) is permitted as long as the subject has not taken a dose within 48-hours of any Baseline or study related efficacy assessment. In addition, the subject must not take more than 8 sildenafil tablets, 6 vardenafil, or 4 tadalafil tablets per month for ED.
- •7. Has PFTs within 6 months (180 days) prior to Baseline/Day 1 with no evidence of significant parenchymal lung disease. Parenchymal lung disease is defined as:
- •Forced expiratory volume in 1 second (FEV 1 ) = 70% (predicted);
- •Forced expiratory volume in 1 second/forced vital capacit
排除标准
- •1.Participation in a device or other interventional clinical studies, with the exception of studies utilizing AIR001, within 1 month (30 days) of Baseline/Day 1 and/or during study participation.
- •2. Participation in a cardio-pulmonary rehabilitation program based upon exercise within 1 month (30 days) prior to Baseline/Day 1 and/or during study participation.
- •3. Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic blood pressure >100 mmHg during Screening.
- •4. Sitting systolic BP < 90 mmHg at Screening or Baseline/Day 1.
- •5. History of orthostatic hypotension or at the time of Screening demonstrates orthostatic hypotension defined as a drop in systolic BP by = 20 mmHg or diastolic BP of = 10 mmHg or the development of significant postural symptoms (syncope, near syncope, lightheadedness, or vertigo) when going from the supine to the standing position as assessed during Screening assessment.
- •6.Has history of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
- •a. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency;
- •b.Pericardial constriction;
- •c. Restrictive or congestive cardiomyopathy;
- •d. Left ventricular ejection fraction < 40% by multiple gated acquisition scan (MUGA), angiography or echocardiography (ECHO) prior to Screening;
- •e. Left ventricular shortening fraction < 22% by ECHO prior to Screening;
- •f. Symptomatic coronary disease.
- •7. Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation.
- •8. Acutely decompensated heart failure within 1 month (30 days) prior to Baseline/Day 1.
- •9. History of atrial septostomy within 6 months (180 days) prior to Baseline/Day 1.
- •10. History of obstructive sleep apnea (treated, untreated or resolved).
- •11. Diagnosis of Down syndrome.
- •12. Moderate to severe hepatic impairment classified as a Child-Pugh Class B or C at Screening.
- •13. Has chronic renal insufficiency as defined by serum creatinine > 2.5 mg/dL or has an estimated Glomular Filtration Rate (eGFR) < 30 mL/min at Screening, or requires dialytic support.
- •14. Has a hemoglobin (Hgb) concentration < 8.5 g/dL at Screening.
- •15. Personal or family history of the following:
- •a. Congenital or acquired methemoglobinemia;
- •b. RBC CYPB5 reductase deficiency.
- •16. History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or any contraindication to receiving methylene blue.
- •17. For subjects with HIV associated PAH, any of the following:
- •Concomitant active opportunistic infections within 6 months (180 days) prior to Screening;
- •Detectable viral load within 3 months (90 days) of Screening;
- •Cluster designation 4 (CD4+) T-cell count < 200 mm within 3 months of Screening;
- •Changes in antiretroviral regimen within 3 months of Screening;
- •Using inhaled pentamidine.
- •18. Receiving chronic treatment with prostacyclin/prostacyclin analogue within 2 months of Baseline/Day 1. Use of prostacyclin for acute vasodilator testing during cardiac catheterization is allowed.
- •19. Requirement of intravenous inotropes within 1 month (30 days) prior to Baseline/Day 1.
- •20. The use of oral or topical nitrates (nitroglycerin, glyceryl trinitrate (GTN), isosorbide dinitrate, and isosorbide mononitrate) within 1 month (30 days) prior to Baseline/Day 1 or througho
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