PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial (PORTICO)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Portopulmonary Hypertension

Treatments: Other: Placebo; Drug: Macitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382016

AC-055-404

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups, including a placebo group

Investigational treatment

Experimental group

Description:

Macitentan film-coated tablet 10 mg once daily.

Treatment:

Drug: Macitentan

Placebo

Placebo Comparator group

Description:

Matching placebo tablet once daily.

Treatment:

Other: Placebo