Study of a new therapeutic agent used to treat portopulmonary hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

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
7. Gastrointestinal bleeding or esophageal varices bleeding < 3 months prior to randomization
8. Treatment with calcium channel blockers, and endothelin receptor antagonist (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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of macitentan on pulmonary vascular resistance (PVR) as compared to placebo in patients with portopulmonary hypertension;<br> Secondary Objective: - To evaluate the effect of macitentan as compared to placebo on cardio-pulmonary hemodynamics, hepatic portal vein pressure, disease severity, and exercise capacity in patients with PoPH.<br> - To evaluate the safety and tolerability of macitentan as compared to placebo in patients with PoPH<br> - To evaluate the pharmacokinetics (PK) of macitentan and its active metabolite ACT-132577 in subjects with PoPH<br> ;<br> Primary end point(s): Primary efficacy endpoint<br> Relative change from Baseline to Week 12 in PVR. <br> ;Timepoint(s) of evaluation of this end point: Screening, Week 12

Secondary Outcome Measures

Name	Time	Method

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