PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
NCT ID: NCT02382016
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2015-06-23
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Investigational treatment
Macitentan film-coated tablet 10 mg once daily.
Macitentan
Macitentan film-coated tablet 10 mg once daily.
Placebo
Matching placebo tablet once daily.
Placebo
Matching placebo tablet once daily.
Interventions
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Macitentan
Macitentan film-coated tablet 10 mg once daily.
Placebo
Matching placebo tablet once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of portopulmonary hypertension
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Loïc Perchenet, PhD
Role: STUDY_DIRECTOR
Actelion
Locations
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Mayo Clinic -Clinical Studies Unit
Phoenix, Arizona, United States
UCSD
La Jolla, California, United States
David Geffen School of Medicine, UCLA
Los Angeles, California, United States
Keck School of Medicine
Los Angeles, California, United States
UCSF
San Francisco, California, United States
University of Colorado Health Sciences Center Aurora
Aurora, Colorado, United States
University of Florida - Divison of Pulmonary Critical Care & Sleep
Gainesville, Florida, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
Mayo Clinic Florida - Pulmonary Dept.
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
South Miami Hospital
South Miami, Florida, United States
Emory Healthcare
Atlanta, Georgia, United States
Piedmont Healthcare
Austell, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Boston University
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic - Department of Cardiovascular Medicine
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Montefiore
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
São Paulo, , Brazil
Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U
Prague, , Czechia
IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
Prague, , Czechia
CHRU de Grenoble, Hôpital Albert Michallon
Grenoble, Auvergne-Rhône-Alpes, France
CHRU Hôpital Cavale Blanche Brest
Brest, Brittany Region, France
CHU Côte de Nacre, Service de Pneumologie
Caen, , France
Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"
Lille, , France
Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"
Lyon, , France
Hôpital Kremlin Bicêtre Service de Pneumologie
Paris, , France
Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"
Rennes, , France
CHU Rouen
Rouen, , France
CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine
Toulouse, , France
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, , Germany
Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392
Giessen, , Germany
Medizinische Hochschule Hannover, Abteilung Pneumologie
Hanover, , Germany
Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination
Heidelberg, , Germany
Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie
Leipzig, , Germany
Hospital Clinico i Provincial Servicio de Neumología
Barcelona, , Spain
Hospital Universitario12 Octubre
Madrid, , Spain
NHS Greater Glasgow and Clyde Trust
Glasgow, Scotland, United Kingdom
The Royal Free Hospital/ Cardiology Department
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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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.
Sitbon 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AC-055-404
Identifier Type: -
Identifier Source: org_study_id
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