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

Ferring

Status and phase

Completed

Phase 2

Conditions

Septic Shock

Treatments

Drug: FE 202158

Study type

Interventional

Funder types

Industry

Identifiers

NCT01612676

000025

2012-001254-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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