A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension - PORTICO

ACTELION Pharmaceuticals Ltd.0 个研究点目标入组 85 人开始时间: 2015年6月19日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1) Male or female 18 years of age with symptomatic PoPH:
•Documented diagnosis of portal hypertension
•PAH by right-heart catheterization at screening
•- Mean pulmonary arterial pressure (mPAP) = 25 mmHg
•- Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) = 15 mmHg
•2) Pulmonary vascular resistance (PVR) = 4 Wood Units or = 320 dyn.s.cm-5 at screening
•3) 6MWD = 50 m at screening
•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 74
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Severe hepatic impairment, as defined by Child-Pugh Class C liver disease or MELD score = 19
•2. Systolic blood pressure (SBP) < 90 mmHg at Screening
•3. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 X the upper limit of the normal range (ULN) at Screening
•4. Bilirubin = 3 mg/dL at Screening
•5. Grades 2, 3, or 4 hepatic encephalopathy
•6. History of liver transplantation or transplantation expected within 3 months after randomization
•7. Gastrointestinal bleeding or esophageal varices bleeding < 3 months prior to randomization
•8. Treatment with endothelin receptor antagonists (ERA), i.v./s.c. or oral prostanoids within 3 months prior to randomization
•9. Treatment with interferon within 3 months prior to randomization
•10. Treatment with strong cytochrome P450 (CYP) 3A4 inducers within 4 weeks prior to randomization
•11. Treatment with strong CYP3A4 inhibitors within 4 weeks prior to randomization

发起方