Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock - Full Text View

Purpose

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.

Condition	Intervention	Phase
Septic Shock	Drug: FE 202158	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.

Resource links provided by NLM:

MedlinePlus related topics: Shock

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Proportion of patients maintaining target/adequate Mean Arterial Pressure (MAP) without norepinephrine until out of shock or end of treatment [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Infusion rates and cumulative dose of FE 202158 [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Infusion rates and cumulative dose of norepinephrine [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Time to septic shock resolution [ Time Frame: Day 1 up to day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma concentration of FE 202158 [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Blood pressure: Systolic, diastolic and mean arterial pressure [ Time Frame: Day 1 up to 7 ] [ Designated as safety issue: No ]
Heart rate [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Urinary output [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Fluid balance [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Safety - Changes in vital signs, MAP, Electro Cardiography (ECG), arterial lactate level, clinical chemistry, haematology, haemostasis and urinalysis [ Time Frame: Day 1 up to day 7 ] [ Designated as safety issue: No ]
Safety - Type, frequency and intensity of adverse events [ Time Frame: Day 1 up to day 7, day 28 ] [ Designated as safety issue: No ]
Morbidity - Time frame [ Time Frame: Day 1 up to day 28 ] [ Designated as safety issue: No ]
Mortality - Rate [ Time Frame: Day 1 up to day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2012
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Drug FE 202158	Drug: FE 202158

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612676

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Locations

Belgium
Saint-Luc University Hospital	Recruiting
Brussels, Belgium
Erasme Hospital Free University of Brussels	Recruiting
Brussels, Belgium
University Hospital Brussels	Recruiting
Brussels, Belgium
Denmark
Hvidovre Hospital	Recruiting
Hvidovre, Denmark

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01612676 History of Changes
Other Study ID Numbers:	000025, 2012-001254-26
Study First Received:	May 11, 2012
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Ethics Committee Denmark: Danish Health and Medicines Authority Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:

Shock
Shock, Septic
Pathologic Processes
Sepsis

Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 22, 2013