PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial

Portopulmonary Hypertension Clinical Trial

— PORTICO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382016
• Other study ID #: AC-055-404
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2019
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 31, 2018
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Portopulmonary Hypertension

Intervention

Drug:
• Macitentan
Macitentan film-coated tablet 10 mg once daily.

Other:
• Placebo
Matching placebo tablet once daily.

Locations

Country	Name	City	State
Brazil	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)	Sao Paulo
Czechia	IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)	Prague
Czechia	Lékarská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U	Prague
France	CHRU Hôpital Cavale Blanche Brest	Brest	Bretagne
France	CHU Côte de Nacre, Service de Pneumologie	Caen
France	CHRU de Grenoble, Hôpital Albert Michallon	Grenoble	Rhône- Alpes
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
Germany	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	Hannover
Germany	Thoraxklinik des Universitätsklinikums Heidelberg Zentrum für pulmonale Hypertonie Studienkoordination	Heidelberg
Germany	Universitätsklinikum Leipzig, Department Innere Medizin, Abteilung Pneumologie	Leipzig
Spain	Hospital Clinico i Provincial Servicio de Neumología	Barcelona
Spain	Hospital Universitario12 Octubre	Madrid
United Kingdom	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 States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Emory Healthcare	Atlanta	Georgia
United States	University of Colorado Health Sciences Center Aurora	Aurora	Colorado
United States	Piedmont Healthcare	Austell	Georgia
United States	Boston University	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic - Department of Cardiovascular Medicine	Cleveland	Ohio
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	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida - Divison of Pulmonary Critical Care & Sleep	Gainesville	Florida
United States	Methodist Hospital	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Mayo Clinic Florida - Pulmonary Dept.	Jacksonville	Florida
United States	University of Florida College of Medicine	Jacksonville	Florida
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	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic -Clinical Studies Unit	Phoenix	Arizona
United States	UPMC Montefiore	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Methodist Hospital	San Antonio	Texas
United States	UCSF	San Francisco	California
United States	South Miami Hospital	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Brazil,  Czechia,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)	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
Secondary	Change From Baseline to Week 12 in WHO Functional Class (FC)	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
Secondary	Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)	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
Secondary	Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)	mRAP is the mean blood pressure in the right atrium of the heart.	From enrollment/baseline to Week 12 in the DB treatment period
Secondary	Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)	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
Secondary	Change From Baseline to Week 12 in Cardiac Index	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
Secondary	Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)	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
Secondary	Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2)	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