PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
PORTICO
A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension
1 other identifier
interventional
85
7 countries
52
Brief Summary
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2015
Typical duration for phase_4
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
November 23, 2018
CompletedMarch 30, 2025
March 1, 2025
2.3 years
March 3, 2015
October 25, 2018
March 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).
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 Outcomes (8)
Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)
From enrollment/baseline to Week 12 in the DB treatment period
Change From Baseline to Week 12 in WHO Functional Class (FC)
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)
From enrollment/baseline to Week 12 in the DB treatment period
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
From enrollment/baseline to Week 12 in the DB treatment period
Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)
From enrollment/baseline to Week 12 in the DB treatment period
- +3 more secondary outcomes
Study Arms (2)
Investigational treatment
EXPERIMENTALMacitentan film-coated tablet 10 mg once daily.
Placebo
PLACEBO COMPARATORMatching placebo tablet once daily.
Interventions
Macitentan film-coated tablet 10 mg once daily.
Eligibility Criteria
You may qualify if:
- Male or female of at least 18 years of age
- Confirmed diagnosis of portopulmonary hypertension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (52)
Mayo Clinic -Clinical Studies Unit
Phoenix, Arizona, 85054, United States
UCSD
La Jolla, California, 92093, United States
David Geffen School of Medicine, UCLA
Los Angeles, California, 90025-1690, United States
Keck School of Medicine
Los Angeles, California, 90033, United States
UCSF
San Francisco, California, 91413-2204, United States
University of Colorado Health Sciences Center Aurora
Aurora, Colorado, 80045, United States
University of Florida - Divison of Pulmonary Critical Care & Sleep
Gainesville, Florida, 32610, United States
University of Florida College of Medicine
Jacksonville, Florida, 32209, United States
Mayo Clinic Florida - Pulmonary Dept.
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
South Miami Hospital
South Miami, Florida, 33143, United States
Emory Healthcare
Atlanta, Georgia, 30322, United States
Piedmont Healthcare
Austell, Georgia, 30106, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
Boston University
Boston, Massachusetts, 02118, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131-0001, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic - Department of Cardiovascular Medicine
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Montefiore
Pittsburgh, Pennsylvania, 15213, United States
Baylor University Medical Center
Dallas, Texas, 75226, United States
University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550
Dallas, Texas, 75390-8550, United States
Methodist Hospital
Houston, Texas, 77030, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53705-2281, United States
Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre
Porto Alegre, 92020-090, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
São Paulo, 05403-000, Brazil
Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U
Prague, 128 08, Czechia
IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
Prague, 140 21, Czechia
CHRU de Grenoble, Hôpital Albert Michallon
Grenoble, Auvergne-Rhône-Alpes, 38043, France
CHRU Hôpital Cavale Blanche Brest
Brest, Brittany Region, 29609, France
CHU Côte de Nacre, Service de Pneumologie
Caen, 14033, France
Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"
Lille, 59037, France
Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"
Lyon, 69677, France
Hôpital Kremlin Bicêtre Service de Pneumologie
Paris, 94275, France
Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"
Rennes, 35033, France
CHU Rouen
Rouen, 76031, France
CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine
Toulouse, 31059, France
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307, Germany
Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392
Giessen, 35392, Germany
Medizinische Hochschule Hannover, Abteilung Pneumologie
Hanover, 30625, Germany
Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination
Heidelberg, 69126, Germany
Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie
Leipzig, 04103, Germany
Hospital Clinico i Provincial Servicio de Neumología
Barcelona, 08036, Spain
Hospital Universitario12 Octubre
Madrid, 28041, Spain
NHS Greater Glasgow and Clyde Trust
Glasgow, Scotland, G11 6NT, United Kingdom
The Royal Free Hospital/ Cardiology Department
London, NW3 2QG, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, S10 2RX, United Kingdom
Related Publications (2)
Raevens S, Fallon MB. PORTICO: First Randomized Controlled Trial of Vasomodulator Therapy in Portopulmonary Hypertension. Hepatology. 2020 May;71(5):1870-1872. doi: 10.1002/hep.31166. No abstract available.
PMID: 32031690DERIVEDSitbon O, Bosch J, Cottreel E, Csonka D, de Groote P, Hoeper MM, Kim NH, Martin N, Savale L, Krowka M. Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2019 Jul;7(7):594-604. doi: 10.1016/S2213-2600(19)30091-8. Epub 2019 Jun 6.
PMID: 31178422DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Trial Disclosure Desk
- Organization
- Actelion Pharmaceuticals Ltd.
Study Officials
- STUDY DIRECTOR
Loïc Perchenet, PhD
Actelion
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 6, 2015
Study Start
June 23, 2015
Primary Completion
October 25, 2017
Study Completion
October 31, 2018
Last Updated
March 30, 2025
Results First Posted
November 23, 2018
Record last verified: 2025-03