drugset / Trial / NCT01640964

An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension

NCT01640964

Phase 2 Completed 47 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).

Timeline

Start
2013-04
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Serelaxin Protein / enzyme biologic 30 ug/kg Intravenous
Subject Terlipressin Peptide 2 mg Intravenous

Indications