NL-OMON45109已完成4 期
A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR
Actelion Pharmaceuticals0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1.Signed informed consent prior to any study-mandated procedure
- •2.Symptomatic pulmonary arterial hypertension (PAH)
- •3.World Health Organization (WHO) Functional Class (FC) I to III
- •4.PAH etiology belonging to one of the following groups according to Nice classification:
- •1.1 Idiopathic PAH
- •1.2 Heritable PAH
- •1.3 Drug- and toxin-induced PAH
- •1.4.1 PAH associated with connective tissue disease
- •1.4.4 PAH associated with congenital heart diseases: only simple (atrial septal defect, ventricular septal defect, patent ductus arteriosus) congenital systemic to pulmonary shunts at least 2 year post surgical repair
- •5.Hemodynamic diagnosis of PAH confirmed by right heart catheterization (RHC) performed between Day -28 and Day 1 (inclusion RHC; RHC data obtained at study site within this time frame, prior to obtaining signed informed consent, are acceptable) showing:
- •mPAP >= 25 mmHg and
- •o PCWP or LVEDP <= 12 mmHg and PVR >= 4 Wood Units (WU) (320 dyn.sec.cm-5) or
- •o 12 mmHg <= PCWP or LVEDP <= 15 mmHg and PVR >= 6WU (480 dyn.sec.cm-5)
- •6.6-minute walk distance (6MWD) >= 150 m during screening
- •7.For patients treated with oral loop diuretics, treatment dose must be stable since at least 1 month prior to the inclusion RHC.
- •8.For patients treated with PDE-5 inhibitors, treatment dose must be stable since at least 3 months prior to the inclusion RHC (initiation of PDE-5 inhibitors during screening is allowed after all screening assessments have been performed).
- •9.For patients treated with beta blockers, treatment dose must be stable since at least 1 month prior to the inclusion RHC.
- •10.Men or women >=18 and < 75 years. For patients aged >= 65 and < 75 years, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
- •11.Women of childbearing potential must:
- •a. Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, and
- •b. Agree to use reliable methods of contraception from screening up to 30 days after study treatment discontinuation, and
- •c. Agree to perform monthly pregnancy tests up to 30 days after study treatment discontinuation
排除标准
- •1.Body weight < 40 kg
- •2.Body mass index (BMI) > 35kg/m2. For patients with 30kg/m2 < BMI > 35kg/m2, an eligibility form will be submitted to a Steering Committee member who will reserve the right to exclude the patient.
- •3.Pregnancy, breastfeeding or intention to become pregnant during the study
- •4.Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
- •5.Known concomitant life-threatening disease with a life expectancy < 12 months
- •6.Any condition likely to affect protocol or treatment compliance
- •7.Hospitalization for PAH (except for diagnosis of PAH) within 3 months prior to informed consent signature
- •8.Left atrial volume indexed for body surface area (BSA) >= 43mL/m2 by echocardiography or cardiac MRI
- •9.Moderate to severe left-heart valvular disease
- •10.History of pulmonary embolism or deep vein thrombosis
- •11.Presence of one or more of the following signs of relevant lung disease at any time up to screening:
- •o Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% of predicted (eligible only if no or mild interstitial lung disease on computed tomography).
- •o FVC < 60% of predicted.
- •o Forced expiratory volume in one second (FEV1) < 60% of predicted.
- •12. Moderate to severe restrictive lung disease (i.e., total lung capacity < 60% of predicted value) at any time prior to enrollment.
- •13.Historical evidence of significant coronary artery disease established by:
- •o History of myocardial infarction or
- •o More than 50% stenosis in a coronary artery (by percutaneous coronary intervention or angiography) or
- •o Elevation of the ST segment on electrocardiogram or
- •o History of coronary artery bypass grafting or
- •o Stable angina
- •14. Known uncontrolled diabetes mellitus (in the opinion of the investigator)
- •15. Severe renal insufficiency (calculated creatinine clearance < 30 mL/min)
- •17.Systolic blood pressure < 90 mmHg
- •18.Severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × ULN accompanied by an AST elevation > ULN at Screening.
- •19.Hemoglobin < 100g/L
- •20.Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of the normal range
- •21.Need for dialysis
- •22.Responders to acute vasoreactivity test based on medical history
- •23.Prior use of endothelin receptor antagonists, stimulators of soluble guanylate cyclase or prostacyclin or prostacyclin analogs
- •24.Treatment with strong inducers of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John*s Wort)
- •25.Treatment with strong inhibitors of CYP3A4 within 4 weeks prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir)
- •26.Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation).
- •27.Hypersensitivity to any endothelin receptor antagonist or any excipients of the formulation of macitentan (lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, polyvinyl alcohol, polysorbate, titanium dioxide, talc, xanthan gum, and lecithin soya)
- •28.Claustrophobia
- •29.MRI-incompatible permanent c
研究者
相似试验
进行中（未招募）
1 期
A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary Arterial HypertensionEUCTR2014-004066-20-DEActelion Pharmaceuticals Ltd.87
进行中（未招募）
1 期
A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.Pulmonary Arterial HypertensionMedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-004066-20-GBActelion Pharmaceuticals Ltd.100
进行中（未招募）
1 期
A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary Arterial HypertensionEUCTR2014-004066-20-NLActelion Pharmaceuticals Ltd.87
进行中（未招募）
1 期
A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertensioPulmonary arterial hypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2018-000145-39-PLActelion Pharmaceuticals Ltd55
已完成
2 期
A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertensio4. PAH belonging to Nice 2013 Updated Classification Group 1 (including Down syndrome) and of one of the following etiologies: - Idiopathic (iPAH)- Heritable (hPAH)- aPAH-CHD: - PAH with co-incidental CHD - Post-operative PAH (persisting / recurring / developing = 6 months after repair of CHD)- Drug or toxin induced- PAH associated with HIV - PAH associated with connective tissue disease (PAH aCTD)I27.0Primary pulmonary hypertensionDRKS00015024Actelion Pharmaceuticals Ltd.63