EUCTR2014-004624-21-CZ
Active, not recruiting
Phase 1
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
ConditionsPortopulmonary hypertensionMedDRA version: 20.0Level: PTClassification code 10067281Term: Portopulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsOpsumit
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Portopulmonary hypertension
- Sponsor
- ACTELION Pharmaceuticals Ltd.
- Enrollment
- 84
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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