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

NCT ID: NCT02929407

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-09-27

Brief 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).

Conditions

Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FE 204205

Group Type: EXPERIMENTAL

FE 204205

Intervention Type: DRUG

In Part 1 of the trial, each subject will receive increasing IV doses of FE 204205, given once daily as 2 hour infusion, on three consecutive days.

In Part 2 of the trial, each subject will receive a 2 hour IV infusion of the maximum tolerated dose of FE 204205 as defined in Part 1 of the trial.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

In Part 2 of the trial, each subject will receive a 2 hour IV infusion of placebo.

Interventions

FE 204205

In Part 1 of the trial, each subject will receive increasing IV doses of FE 204205, given once daily as 2 hour infusion, on three consecutive days.

In Part 2 of the trial, each subject will receive a 2 hour IV infusion of the maximum tolerated dose of FE 204205 as defined in Part 1 of the trial.

Intervention Type: DRUG

Placebo

In Part 2 of the trial, each subject will receive a 2 hour IV infusion of placebo.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Hospital Clinic de Barcelona, Departamento hepatología

Barcelona, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-001078-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000249

Identifier Type: -

Identifier Source: org_study_id