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

March 28, 2025 updated by: Actelion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 92020-090
        • Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre
      • Sao Paulo, Brazil, 05403-000
        • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
  • Czechia
      • Prague, Czechia, 128 08
        • Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U
      • Prague, Czechia, 140 21
        • IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
  • France
      • Caen, France, 14033
        • CHU Côte de Nacre, Service de Pneumologie
      • Lille, France, 59037
        • Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"
      • Lyon, France, 69677
        • Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"
      • Paris, France, 94275
        • Hôpital Kremlin Bicêtre Service de Pneumologie
      • Rennes, France, 35033
        • Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"
      • Rouen, France, 76031
        • CHU Rouen
      • Toulouse, France, 31059
        • CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine
    • Bretagne
      • Brest, Bretagne, France, 29609
        • CHRU Hôpital Cavale Blanche Brest
    • Rhône- Alpes
      • Grenoble, Rhône- Alpes, France, 38043
        • CHRU de Grenoble, Hôpital Albert Michallon
  • Germany
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
      • Giessen, Germany, 35392
        • Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Abteilung Pneumologie
      • Heidelberg, Germany, 69126
        • Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico i Provincial Servicio de Neumología
      • Madrid, Spain, 28041
        • Hospital Universitario12 Octubre
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • The Royal Free Hospital/ Cardiology Department
      • Sheffield, United Kingdom, S10 2RX
        • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • NHS Greater Glasgow and Clyde Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic -Clinical Studies Unit
    • California
      • La Jolla, California, United States, 92093
        • UCSD
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine
      • Los Angeles, California, United States, 90025-1690
        • David Geffen School of Medicine, UCLA
      • San Francisco, California, United States, 91413-2204
        • UCSF
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center Aurora
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Divison of Pulmonary Critical Care & Sleep
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida - Pulmonary Dept.
      • Miami, Florida, United States, 33136
        • University of Miami
      • South Miami, Florida, United States, 33143
        • South Miami Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Healthcare
      • Austell, Georgia, United States, 30106
        • Piedmont Healthcare
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico Health Science Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Department of Cardiovascular Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Montefiore
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor University Medical Center
      • Dallas, Texas, United States, 75390-8550
        • University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2281
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational treatment
Macitentan film-coated tablet 10 mg once daily.
Drug: Macitentan
Macitentan film-coated tablet 10 mg once daily.
Other Names:
  • ACT-064992
Placebo Comparator: Placebo
Matching placebo tablet once daily.
Other: Placebo
Matching placebo tablet once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period
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).
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period
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.
From enrollment/baseline to Week 12 in the DB treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Loïc Perchenet, PhD, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2015

Primary Completion (Actual)

October 25, 2017

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimated)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-055-404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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