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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Liver Unit, Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Change from baseline in fasting hepatic venous pressure gradient (HVPG)
Time frame: Baseline, after 2 hours
Change from baseline in fasting hepatic venous pressure gradient (HVPG)
Time frame: Baseline, after 1 hour
Change from baseline in fasting hepatic blood flow
Measured from the concentration of indocyanine green (ICG) in the hepatic venous blood vs peripheral venous blood using the Fick Principle
Time frame: Baseline, after 2 hours
Change from baseline in inferior vena cava pressure
Time frame: Baseline, after 2 hours
Change from baseline in cardiac index
Time frame: Baseline, after 2 hours
Change from baseline in systemic vascular resistance index
Time frame: Baseline, after 2 hours
Number of participants with adverse events
Adverse events (AE) reporting will be summarized based on number of patients reported with abnormal laboratory values, clinically significant AE, serious adverse events or death
Time frame: 4 weeks
Change from baseline in blood biomarker measurements
Time frame: Baseline, after 2 hours
Change from baseline in aortic pulse wave velocity
Time frame: Baseline, after 2 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.