Clinical trial NCT02382016: PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Portopulmonary Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).
timeFrame: From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period
Secondary outcomes:
measure: Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in WHO Functional Class (FC)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in Cardiac Index
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
measure: Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2)
timeFrame: From enrollment/baseline to Week 12 in the DB treatment period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic -Clinical Studies Unit
state: Arizona
city: La Jolla
country: United States
facility: UCSD
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center Aurora
state: Colorado
city: Gainesville
country: United States
facility: University of Florida - Divison of Pulmonary Critical Care & Sleep
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida - Pulmonary Dept.
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: South Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Austell
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Department of Cardiovascular Medicine
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Montefiore
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Division of NeuroCritical Care 75390-8550
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Porto Alegre
country: Brazil
facility: Servico de Hipertensao Pulmonar - Complexo Hospitalar Santa Casa Irmandade Santa de Misericordia de Porto Alegre
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
city: Prague
country: Czechia
facility: Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U
city: Prague
country: Czechia
facility: IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
city: Brest
country: France
facility: CHRU Hôpital Cavale Blanche Brest
state: Bretagne
city: Grenoble
country: France
facility: CHRU de Grenoble, Hôpital Albert Michallon
state: Rhône- Alpes
city: Caen
country: France
facility: CHU Côte de Nacre, Service de Pneumologie
city: Lille
country: France
facility: Hôpital cardiologique, Service de cardiologie 59037 Lille Cedex"
city: Lyon
country: France
facility: Hôpital Cardiologique et Pneumologique Louis Pradel 69677 Bron cedex"
city: Paris
country: France
facility: Hôpital Kremlin Bicêtre Service de Pneumologie
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU Rennes Service de Cardiologie et des Maladies Vasculaires Rennes Cedex 9 35033"
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Larrey Hôpital de Jour et Semaine
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH Justus-Liebig Universität Giessen 35392
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Abteilung Pneumologie
city: Heidelberg
country: Germany
facility: Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie
city: Barcelona
country: Spain
facility: Hospital Clinico i Provincial Servicio de Neumología
city: Madrid
country: Spain
facility: Hospital Universitario12 Octubre
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Trust
state: Scotland
city: London
country: United Kingdom
facility: The Royal Free Hospital/ Cardiology Department
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Study officials:
affiliation: Actelion
name: Loïc Perchenet, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.