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Completed

NCT Number: NCT02382016

PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

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

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Key information

Conditions

Portopulmonary Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre, Porto Alegre, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macitentan

Drug

Macitentan film-coated tablet 10 mg once daily.

Other names: ACT-064992

Placebo

Other

Matching placebo tablet once daily.

Primary outcomes

  1. Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).

    Time frame: From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period

    The relative change from baseline to Week 12 in PVR is expressed as a ratio of Week 12 to baseline PVR.

Secondary outcomes

  1. Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

  2. Change From Baseline to Week 12 in WHO Functional Class (FC)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    Changes from baseline to Week 12 in WHO FC were dichotomized as worsening (i.e., change > 0) versus no change or improvement (i.e., change ≤ 0). Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.

  3. Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    NT-proBNP functions as a strong indicator of prognosis in patients with pulmonary hypertension (PH). The relative change from baseline to Week 12 in NT-proBNP is expressed as a ratio of Week 12 to baseline NT-proBNP.

  4. Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    mRAP is the mean blood pressure in the right atrium of the heart.

  5. Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    mPAP is the mean blood pressure inside the pulmonary artery which moves the blood from the heart to the lungs. Monitoring of mPAP can detect small changes in the function of the heart.

  6. Change From Baseline to Week 12 in Cardiac Index

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    The cardiac index is an assessment of the function of the heart and relates the cardiac output to the patient's body size (the patient's body surface area).

  7. Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    TPR is the resistance the pulmonary circulation that must be overcome in order for the blood flow to occur. It takes into account the blood pressure in the pulmonary arteries and the cardiac output. It is an important measurement to monitor the function of the pulmonary circulation and detect disease progression or improvement.

  8. Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2)

    Time frame: From enrollment/baseline to Week 12 in the DB treatment period

    SVO2 help assess tissue oxygen delivery. It describes the percentage of oxygen bound to hemoglobin in the blood which returns to the heart. This reflects the amount of residual oxygen in the blood after oxygen extraction by the tissues throughout the body.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

Acronym: PORTICO

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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