PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

Summary

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

Timeline

Start

2015-06-23

Primary completion

2017-10-25

Completion

2018-10-31

Outcome

Met primary endpoint

registry analysis (superiority test); Macitentan 10 mg vs Placebo; p = 0.0001; ratio of geometric means 0.65 (95% CI 0.59 to 0.72); ANCOVA NCT02382016 ↗

paper Macitentan significantly improved pulmonary vascular resistance in portopulmonary hypertension patients, with no hepatic safety concerns. PMID 31178422 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macitentan	Other / unclassified	10 mg	—

Indications