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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01612676
First received: May 11, 2012
Last updated: November 3, 2014
Last verified: November 2014
  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:


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 ]

Enrollment: 31
Study Start Date: June 2012
Study Completion Date: November 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Erasme Hospital Free University of Brussels
Brussels, Belgium
Saint-Luc University Hospital
Brussels, Belgium
University Hospital Brussels
Brussels, Belgium
Denmark
Hvidovre Hospital
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: November 3, 2014
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
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014