PORTICO
Research type
Research Study
Full 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
IRAS ID
171675
Contact name
John Gerard Coghlan
Contact email
Sponsor organisation
ACTELION Pharmaceuticals Ltd.
Eudract number
2014-004624-21
Research summary
Portopulmonary hypertension is a form of pulmonary arterial hypertension (PAH), a disorder of the blood vessels in the lungs that has arisen as a consequence of liver disease.
In patients with pulmonary arterial hypertension (PAH),less flexible vessels make it difficult for the heart to pump enough blood through the lungs and must work harder to do so. If the heart has to work harder than usual over a long period of time, the right side of the heart becomes enlarged and functions poorly which can eventually lead to heart failure.To date, no PAH targeted therapy has demonstrated efficacy in randomised, controlled clinical trial in PoPH patient population.
The purpose of this study is to find out if macitentan can safely improve the blood pressure in these blood vessels in a randomised, double-blind, placebo-controlled trial. In addition, the effect of macitentan on the high blood pressure in the liver will be tested if research centres have the facilities to perform the assessment.
In order to measure the safety and effectiveness of macitentan for treating portopulmonary hypertension, this study is designed to test the medication in comparison to a placebo or “inactive medication”.The study will be carried out in approximately 45 centres in 7 countries around the world with up to 84 participants that will be invited to participate.
Eligible patients, men and women of 18years and older will be randomly assigned to receive either the study medication or the placebo. They will have a 50% chance of receiving macitentan.
The study will consist of a 28 days screening period, a 24 week treatment period (double-blind and open-label treatment period) and a 30-day safety follow up at the end of the study.
During the study, the participants will undergo a number of procedures including a physical exam, blood test, completion of questionnairesNT-proBNP test, right heart catheterisation, Hepatic vein catheterisation and a 6 minute walk test.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0337
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion