Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

NCT ID: NCT01612676

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-11-30

Brief Summary

The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

Conditions

Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug

FE 202158

Group Type: EXPERIMENTAL

FE 202158

Intervention Type: DRUG

Interventions

FE 202158

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form by the patient or a legal representative according to local regulations'
• Man or women 18 years of age or older
• Body weight below 115 kg for male patients and 100 kg for female patients
• Proven or suspected infection
• Septic shock, i.e. vasodilatory hypotension requiring vasopressor support
• Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication

Exclusion Criteria

• Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina)
• Known or suspected endocarditis
• Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test
• Known or suspected cardiac failure
• Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C
• Pregnancy or breastfeeding
• Any cause of hypotension other than early septic shock
• Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion
• Proven or suspected acute mesenteric ischemia, as judged by the investigator
• Known episode of septic shock within 1 month prior to screening
• Death anticipated within 24 hours, or due to the underlying disease within 3 months
• Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
• Brain injury within current hospitalisation
• Present hospitalisation with burn injury
• Symptomatic peripheral vascular disease including Raynaud's syndrome
• Previously included in this trial
• Intake of an Investigational Medicinal Product (IMP) within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
• Known participation in another interventional clinical trial
• Considered by the investigator to be unsuitable to participate in the trial for any other reason

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

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Erasme Hospital Free University of Brussels

Brussels, , Belgium

Saint-Luc University Hospital

Brussels, , Belgium

University Hospital Brussels

Brussels, , Belgium

Hvidovre Hospital

Hvidovre, , Denmark

Countries

Belgium; Denmark

Other Identifiers

2012-001254-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000025

Identifier Type: -

Identifier Source: org_study_id