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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 after 2?h of peripheral i.v. serelaxin infusion (80??g/kg/day for 60?min followed by 30??g/kg/day for at least 60?min). Secondary endpoints included the change from baseline in hepatic blood flow and systemic haemodynamics (cardiac index, systemic vascular resistance index and aortic pulse wave velocity). Short-term safety and tolerability of serelaxin were assessed. RESULTS:A total of 17 participants were screened, 15 were randomised and 11 completed the study (n =?9 serelaxin, n =?2 placebo). Reasons for withdrawal were baseline HVPG

SUBMITTER: Gifford FJ 

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

REPOSITORIES: biostudies-literature

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

Gifford Fiona J FJ   Dunne Philip D J PDJ   Weir Graeme G   Ireland Hamish H   Graham Catriona C   Tuck Sharon S   Hayes Peter C PC   Fallowfield Jonathan A JA  

Trials 20200312 1


<h4>Background</h4>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.<h4>Methods</h4>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  ...[more]

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