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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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