A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal Hypertension

• Status: Terminated
• Trial end date: 2017-09-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with cirrhotic portal hypertension.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

Criteria

Inclusion Criteria:

• Confirmed evidence of cirrhosis

• From medical history anticipated hepatic venous pressure gradient greater than equal to (≥)12 mmHg

Exclusion Criteria:

• Co-existing disease e.g. significant organ failure and decompensated cirrhosis

• Type 1 hepatorenal syndrome

• Acute-on-chronic liver failure

• Hepatic encephalopathy ≥grade 2

• Hepatocellular carcinoma

• History of underlying chronic heart disease

• Use of vasopressin or terlipressin within 7 days prior to dosing