NCT02669875

Serelaxin To Lower Portal Pressure

Serelaxin To Lower Portal Pressure in Patients With Cirrhosis and Portal Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Portal hypertension (an increase in blood pressure in the portal vein that carries the blood from the intestine and spleen to the liver) underlies most of the serious complications of liver cirrhosis. This randomised placebo controlled study in people with liver cirrhosis evaluates the acute effects serelaxin (RLX030) infusion on portal hypertension and liver blood flow.

Detailed description

This study will investigate the effects of the investigational drug serelaxin (a recombinant form of the peptide human relaxin-2) on portal hypertension in patients with liver cirrhosis. The investigators will measure portal pressure by hepatic venous pressure gradient (HVPG) and hepatic blood flow by indocyanine green (ICG) clearance to evaluate the potential benefits of the drug. In a recently completed small exploratory open-label phase 2 study (EudraCT no. 201200023626, NCT01640964), Part B demonstrated that serelaxin can lower portal pressure.

Conditions

• Liver Cirrhosis
• Hypertension, Portal

Interventions

Type	Name	Description
DRUG	Serelaxin	Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution
DRUG	Placebo	Placebo solution (20mM sodium acetate pH5) diluted in 5% v/v glucose solution

Timeline

• Start date: 2017-10-18
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2016-02-01
• Last updated: 2018-10-11

Locations

1 site across 1 country: United Kingdom