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

Septic Shock Clinical Trial

Official title:

An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612676
• Other study ID #: 000025
• Secondary ID: 2012-001254-26
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2012
• Last updated: November 3, 2014
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Ethics CommitteeDenmark: Danish Health and Medicines AuthorityDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• FE 202158

Locations

Country	Name	City	State
Belgium	Erasme Hospital Free University of Brussels	Brussels
Belgium	Saint-Luc University Hospital	Brussels
Belgium	University Hospital Brussels	Brussels
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients maintaining target/adequate Mean Arterial Pressure (MAP) without norepinephrine until out of shock or end of treatment		Day 1 up to day 7	No
Primary	Infusion rates and cumulative dose of FE 202158		Day 1 up to day 7	No
Primary	Infusion rates and cumulative dose of norepinephrine		Day 1 up to day 7	No
Primary	Time to septic shock resolution		Day 1 up to day 28	No
Secondary	Plasma concentration of FE 202158		Day 1 up to day 7	No
Secondary	Blood pressure: Systolic, diastolic and mean arterial pressure		Day 1 up to 7	No
Secondary	Heart rate		Day 1 up to day 7	No
Secondary	Urinary output		Day 1 up to day 7	No
Secondary	Fluid balance		Day 1 up to day 7	No
Secondary	Safety - Changes in vital signs, MAP, Electro Cardiography (ECG), arterial lactate level, clinical chemistry, haematology, haemostasis and urinalysis		Day 1 up to day 7	No
Secondary	Safety - Type, frequency and intensity of adverse events		Day 1 up to day 7, day 28	No
Secondary	Morbidity - Time frame		Day 1 up to day 28	No
Secondary	Mortality - Rate		Day 1 up to day 28	No