EUCTR2020-004815-29-DE进行中（未招募）1 期
Open-label, dose escalation study of ularitide for the investigation of hemodynamic effects in patients with pulmonary arterial hypertension (UPAH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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. Male and female patients 18 to 75 years of age
- •2. Known diagnosis of PAH (idiopathic, hereditary, drug-associated, due to connective tissue disease, simple congenital heart defects closed >1 year) with
- •a) PVR >3 WU (determined at last right heart catheterization)
- •b) Mean pulmonary arterial pressure (mPAP) =25 mmHg (determined at last right heart catheterization)
- •c) Pulmonary arterial wedge pressure (PAWP) =15 mmHg (determined at last right heart catheterization)
- •3. Stable PAH background therapy for =3 months including endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5) inhibitors, soluble guanylate cyclase (sGC) stimulators, prostacyclin analogues, prostacyclin-receptor agonists or any combination thereof
- •4. Scheduled for a control visit including right heart catherization
- •5. No morning intake of PAH background medication at the day of ularitide treatment
- •6. Negative pregnancy test (ß-human chorionic gonadotropin) at screening in women of childbearing age
- •7. Ability to understand the purpose and risks of the study and to provide signed and dated written informed consent
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Known diagnosis of
- •a) medium- or high-grade left-sided valvular disease
- •b) hypertrophic obstructive cardiomyopathy
- •c) chronic heart failure
- •d) diastolic heart failure with preserved ejection fraction (HFpEF)
- •e) state post pulmonary embolism
- •f) clinically relevant parenchymal lung diseases as evidenced by
- •- Ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC ratio) of <55% of predicted
- •- Forced vital capacity (FVC) <60% of predicted, and
- •- Diffusion capacity of the lung for carbon dioxide (DLCO) <50% of predicted.
- •All respiratory values must not be older than twelve months at the time of screening and documented in the medical history of the patient. If documented values were older than 12 months from screening, patient must undergo spirometry during screening for determining these values.
- •2. Contraindications for right heart catheterization such as uncontrolled coagulation disorders, uncontrolled disorders of cardiac excitation generation and conduction, permanent pacemaker, implanted defibrillator
- •3. Documented left ventricular ejection fraction <40%
- •4. Documented partial pressure of pulmonary arterial oxygen <50 mmHg (despite oxygen supplementation) and/or partial pressure of carbon dioxide >50 mmHg.
- •5. Uncontrolled severe systemic hypertension at screening, i.e. arterial hypertension >200 mmHg (systolic) or >120 mmHg (diastolic)
- •6. Estimated glomerular filtration rate (eGFR) <30 mL/kg/min at screening
- •7. Severe hepatic impairment or porphyria characterized by elevations of one or both serum transaminases (alanine-aminotransferase, aspartate-aminotransferase) >3 x upper limit of normal (ULN) or bilirubin >3 x ULN at screening
- •8. Use of sGC stimulators within three days prior to start of ularitide treatment
- •9. Use of nitric oxide donors or sacubitril-valsartan within three days prior to start of ularitide treatment
- •10. Known hypersensitivity to the active substance or to any of the excipients of the study drug or other natriuretic peptides
- •11. Known Hepatitis B or C or human immunodeficiency virus infection
- •12. Participation in an interventional clinical trial within one month prior to screening or 5 half-lives of the corresponding investigational medicinal product, whichever is longer
- •13. Active substance abuse
- •14. Legal incapacity or limited legal capacity
- •15. Breastfeeding or pregnancy
- •16. Employees of the sponsor or patients who are employees or relatives of the investigators
- •17. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
研究者
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