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临床试验/EUCTR2015-005223-90-PT
EUCTR2015-005223-90-PT进行中（未招募）1 期

A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1

Bellerophon Pulse Technologies LLC0 个研究点目标入组 188 人开始时间: 2016年5月9日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
188
研究概览入排标准研究者记录与标识符相似试验

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. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments
  • •2. A confirmed diagnosis of PAH Group 1 who have either idiopathic PAH (IPAH), heritable PAH, drug and toxin-induced PAH, associated PAH (APAH) with connective tissue disease (CTD), APAH with repaired simple congenital systemic to pulmonary shunt (i.e., atrial septal defect, ventricular septal defect and/or patent ductus arteriosus; complete repair at least 1 year prior to Screening), APAH with human immunodeficiency virus (HIV), or APAH with portal hypertension
  • •3. Subjects receiving at least one PAH specific therapy (ERA or PDE-5 inhibitor, or inhaled, subcutaneous, or intravenous prostacyclin or a prostacyclin analog) with the same type of therapy for at least 3 months with stable dosing 4 weeks prior to Screening. (Subjects should be receiving optimal therapy according to the disease severity)
  • •4. Subjects using oxygen therapy by nasal cannula for at least 4 weeks prior to Screening
  • •5. PAH diagnosis confirmed by RHC within the previous 5 years, according to the following definitions:
  • •PVR = 400 dynes.sec.cm-5 (5 Wood units)
  • •mPAP = 25 mmHg
  • •PCWP or LVEDP = 15 mmHg
  • •Subjects who otherwise meet all the inclusion criteria and none of the exclusion criteria but have not undergone a RHC within the previous 5 years may be considered eligible for the study if they undergo a RHC and then meet the pulmonary hemodynamics criterion
  • •6. 6MWD = 100 meters and = 450 meters prior to randomization
  • •7. WHO Functional Class II-IV. Subjects with WHO Functional Class IV should be treated with prostacyclin or a prostacyclin analog (subcutaneous or intravenous), plus at least one additional PAH specific therapy (ERA or PDE-5), if available to the subject and reimbursed by health insurance
  • •8. Age between 18 and 80 years (inclusive)
  • •9. Willingness to use INOpulse delivery device for at least 16 hours per day
  • •10. Willingness to continue on study drug until last subject has completed Week 18 assessments (EOS)
  • •11. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female subjects should take adequate precaution to avoid pregnancy.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 160
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 28

排除标准

  • •1. Subjects with known HIV infection who have a history within the past 3 months of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias) at the time of Screening
  • •2. PAH associated with untreated thyroid disorders, glycogen storage disease, Gaucher’s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
  • •3. Subjects with pulmonary conditions that may contribute to PAH including, but not limited to, chronic bronchiectasis, cystic fibrosis, or other pulmonary condition that the Investigator may deem to contribute to the severity of the disease or impair the delivery of iNO due to airway disease
  • •4. Subjects receiving riociguat
  • •5. Subjects receiving oral prostanoids as monotherapy
  • •6. Any subject with unrepaired congenital heart disease or repaired congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria, i.e., PAH associated with non-corrected simple congenital systemic-to-pulmonary shunts, corrected simple congenital systemic-to-pulmonary shunt with residual shunt post repair, or complex systemic-to-pulmonary shunts, corrected or non-corrected, or any other complex congenital heart disease, corrected or non- corrected
  • •7. PAH associated with significant venous or capillary involvement, known or suspected pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
  • •8. Any subject with WHO PH Groups 2, 3, 4 or 5
  • •9. Subjects with any of the following cardiac abnormalities:
  • •a. Underlying cardiomyopathy or aortic or mitral valve disease
  • •b. Left ventricular systolic dysfunction (LVSD), i.e., left ventricular ejection fraction (LVEF) < 40% or left ventricular shortening fraction (LVSF) < 22%, as determined by local reading
  • •c. Current symptomatic coronary artery disease, myocardial infarction within 1 year, or any coronary artery interventions within 6 months
  • •10. Systemic hypertension defined as systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg persistent at Screening after a period of rest (treated or untreated)
  • •11. Subjects with a history of deep vein thrombosis, pulmonary embolism/infarction or prothrombotic disorder must have had chronic thromboembolic pulmonary hypertension (CTEPH) excluded by ventilation/perfusion lung (V/Q) scan
  • •12. Moderate to severe obstructive lung disease defined as both a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value
  • •13. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted; if TLC 60% to 70% predicted, a high resolution CT scan showing diffuse disease or more than mild patchy disease
  • •14. Any subject who develops or has developed a PCWP > 20 mmHg during acute vasodilator testing (AVT)
  • •15. Systemic hypotension defined as SBP < 90 mmHg persistent at Screening after a period of rest
  • •16. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  • •17. On dialysis
  • •18. Acute or chronic physical impairment (other than dyspnea due to PAH) that would limit the ability to comply with study procedures or adherence to therapy (i.e., 6MWT), including carrying and wearing the pulsed delivery device per study protocol, or medical problem(s) likely to preclude completion of the study
  • •19. Pregnant or breastfeeding females at Screening
  • •20. Administered L-arginine within 1 month prior to Scr

研究者

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