A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP).

ABSTRACT:

Background

In preclinical models, recombinant human relaxin-2 (serelaxin) had anti-fibrotic effects and ameliorated portal hypertension (PH). A small exploratory study in patients with cirrhosis also suggested that serelaxin could reduce portal pressure.

Methods

In a phase 2, double-blind, randomised controlled study conducted in a single centre (Royal Infirmary of Edinburgh, UK), male and female adult participants with cirrhosis and clinically significant PH (CSPH; hepatic venous pressure gradient (HVPG) > 10 mmHg) were enrolled. Participants were allocated to serelaxin or placebo in a 3:1 ratio. The placebo was matched to serelaxin on appearance and administration protocol to create and maintain blinding. The primary endpoint was the change from baseline in fasting HVPG af

SUBMITTER: Gifford FJ 

PROVIDER: S-EPMC7066808 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature