EUCTR2014-003952-29-BE进行中（未招募）1 期
Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 20
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
入选标准
- •1. Children aged =6 to <18 years
- •2. Diagnosed with PAH :
- •- Idiopathic (IPAH)
- •- Hereditable (HPAH)
- •- PAH associated with (APAH)
- •o Connective tissue disease
- •o Congenital heart disease with shunt closure more than 6 months ago (no open shunts, confirmed by RHC no less than 4 months after surgery)
- •3. Diagnosis of PAH confirmed by right heart catheterization (RHC) at any time prior to enrolment (for patients with closed shunts – RHC no less than 4 months after surgery)
- •4. Pulmonary arterial hypertension confirmed by a RHC at any time prior to start of study, with mean pulmonary artery pressure (PAPmean) =25 mmHg at rest, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) =15 mmHg, and pulmonary vascular resistance (PVR) >240 dyn•sec•cm-5 (i.e., =3.0 wood units•m2)
- •5. Patients must be on standard of care PAH medications, allowing Endothelin Receptor Antagonists (ERA) and / or Prostacyclin Analogues (PCA), for at least 12 weeks prior to baseline visit.
- •Two groups of patients will be included:
- •o Prevalent: Patients currently on PAH medication (allowing ERA and/or PCA)
- •who need additional treatment (discretion of the investigator)
- •o Incident: Treatment naïve patients initiated on PAH medication (allowing ERA and /or PCA) and then riociguat added once patients are stable on standard of care.
- •5. WHO functional class I - III
- •6. Adolescent females of childbearing potential can only be included in the study if a
- •pregnancy test is negative. Adolescent females of childbearing potential must agree to use
- •adequate contraception when sexually active. ‘Adequate contraception’ is defined as any
- •combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Adequate contraception is required from the signing of the informed consent form up until 6 weeks after the last study drug administration.
- •7. Young men must agree to use adequate contraception when sexually active.
- •8. Written inform consent provided and if applicable child assent provided
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Concomitant use of the following medications: phosphodiesterase (PDE) 5 Inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE Inhibitors (theophylline, dipyridamole), nitrates or NO donors (Such as amyl nitrite) in any form
- •2.Pretreatment with NO donors (e.g. nitrates) within the last 2-weeks before visit 1
- •3. Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization or any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening
- •4. Systolic blood pressure (SBP) more than 5 mmHg lower than the age-, sex- and height-adapted level of the 50th SBP percentile (NHBPEP, 2004)
- •5. History of left-sided heart disease, including valvular disease or heart failure
- •6. Pulmonary hypertension related to conditions other than specified in the inclusion criteria
- •7. WHO functional class IV
- •8. Pulmonary veno-occlusive disease
- •9. Screening aspartate transaminase (AST) and/ or alanine transaminase (ALT) more than 3 times the upper limit of normal (ULN)
- •10. Non-stable disease status, e.g. , signs and symptoms of decompensated right heart failure
- •11. Severe bronchial asthma
- •12. Severe restrictive lung disease
- •13. Severe congenital abnormalities of the lung, thorax, and diaphragm
- •14. Clinically relevant hepatic dysfunction (especially Child Pugh C)
- •15. Renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73m2 e.g. calculated based on Schwartz formula)
- •16. Subject with hypersensitivity to the investigational drug or any of the excipients
- •17. Active smoking of tobacco of any type or quantity
- •18. Subjects with known HIV infection (evaluated by medical history)
- •19. Previous assignment to treatment during this study
- •20. Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- •21. Any condition that, according to treating physician, might jeopardize subject's participation and compliance with procedures indicated in this protocol.
- •22. PH associated with idiopathic interstitial pneumonia (PH-IIP)
研究者
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