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Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01000649
First received: September 30, 2009
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this trial is to examine the safety and tolerability, pharmacokinetics of FE202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 has previously been tested in healthy volunteers.


Condition Intervention Phase
Septic Shock
 Drug: FE 202158
Drug: Sodium Chloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Infusion Proof-of-concept Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of FE 202158 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:
  • Stabilisation of blood pressure - Proportion of patients maintaining target MAP with no open label NE (Norepinephrine) [ Time Frame: Day 1- 7 ] [ Designated as safety issue: No ]
  • Proportion of patients maintaining target MAP [ Time Frame: Day 1-7 ] [ Designated as safety issue: No ]
  • Cumulative dose and infusion rates of open label NE. [ Time Frame: Day 1-7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of FE 202158 in patients (clearance, half life) [ Time Frame: Day 1 - day 7 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Day 1 - day 7 ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Day 1 - day 7 ] [ Designated as safety issue: No ]
  • Vascular leakage [ Time Frame: Day 1 - day 7 ] [ Designated as safety issue: No ]
  • Inflammatory response [ Time Frame: Day 1 - day 7 ] [ Designated as safety issue: No ]
  • Safety - changes in vital signs, clinical chemistry, haemostasis and urinalysis [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]
  • Tolerability - changes in vital signs, clinical chemistry, haemostasis and urinalysis [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]
  • Mortality rate [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]
  • Safety - Frequency and intensity of adverse events [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]
  • Tolerability - Frequency and intensity of adverse events [ Time Frame: Day 1 - day 7, day 28 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: FE 202158
Placebo Comparator: 2 Drug: Sodium Chloride

  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 woman 18 years of age or older
  • Proven or suspected infection
  • Low blood pressure
  • Signs of decreased circulation in the tissues
  • Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication.

Exclusion Criteria:

  • Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible.
  • 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
  • Pregnancy or breastfeeding
  • Any cause of hypotension other than early septic shock
  • Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
  • Proven or suspected acute mesenteric ischemia, as judged by the investigator
  • Known episode of septic shock within 1 month prior to randomisation
  • Underlying chronic heart disease
  • Traumatic brain injury
  • Present hospitalisation with burn injury
  • Symptomatic peripheral vascular disease including Raynaud's syndrome
  • Previously randomised in this trial
  • Intake of an investigational drug 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 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: NCT01000649

Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States
United States, Minnesota
Division of Education and Research SMDC Health System
Duluth, Minnesota, United States
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States
United States, New York
Mount Sinai School of Medicine
New York, New York, United States
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
Belgium
University Hospital Vrije Universiteit
Brussels, Belgium
Erasme Hospital (Free University of Brussels)
Brussels, Belgium
Clinique Universitaire St-Luc
Brussels, Belgium
Service des Soins Intensits
Dinant, Belgium
Canada
St. Paul´s Hospital
Vancouver, Canada
Royal Columbian Hospital
Vancouver, Canada
Denmark
Bispebjerg Hospital
Bispebjerg, Denmark
Rigshospitalet
Copenhagen, Denmark
Hillerød Hospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided by Ferring Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01000649     History of Changes
Other Study ID Numbers: FE 202158 CS02, EudraCT: 2009-010798-19
Study First Received: September 30, 2009
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by Ferring Pharmaceuticals:
V1a agonist

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 23, 2013