PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

• Status: Completed
• Trial end date: 2018-10-31
• Target enrollment: 0
• Participant gender: All

Summary

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Macitentan

Criteria

Main Inclusion Criteria:

• Male or female of at least 18 years of age

• Confirmed diagnosis of portopulmonary hypertension

Main Exclusion Criteria:

• Severe hepatic impairment

• Severe obstructive or restrictive lung disease

• Pulmonary veno-occlusive disease

• Systolic blood pressure (SBP) < 90 mmHg at Screening

• ALT/AST >= 3 x ULN

• Bilirubin >= 3 mg/dL at Screening

• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results