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TERMINATEDPHASE1

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

A Placebo Controlled, Double-blind, Randomised Trial Investigating Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics After Intravenous Administration of FE 204205 in Patients With Cirrhotic Portal Hypertension

NCT02929407•Ferring Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

The trial aimed to evaluate the safety, tolerability, PK and PD of IV FE 204205 in cirrhotic patients with portal hypertension and was planned in 2 parts: Part 1 of the trial was open-label where six subjects were planned to receive three ascending doses of FE 204205, given as infusion over 2 hours on three consecutive days. Part 2 was planned as a randomised, placebo-controlled, double-blind investigation evaluating the effects of a single dose of FE 204205 on portal haemodynamics in 20 subjects who would have received either the maximum tolerated dose (as defined in Part 1) of FE 204205 (n=16) or placebo (n=4).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Hospital Clinic de Barcelona, Departamento hepatología

Barcelona, Spain

Key Dates

Start Date

November 1, 2016

Primary Completion Date

September 27, 2017

Completion Date

September 27, 2017

Last Updated

July 12, 2019

Enrollment

ACTUAL participants

Conditions

Portal Hypertension

Interventions

FE 204205

DRUG

Placebo

DRUG

Natural History of Noncirrhotic Portal Hypertension

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts