NCT01000649

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

June 2, 2017

Completed
Last Updated

September 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

September 30, 2009

Results QC Date

December 13, 2016

Last Update Submit

August 24, 2017

Conditions

Septic Shock

Keywords

V1a agonist

Outcome Measures

Primary Outcomes (4)

  • Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)

    Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method. The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

    Day 1 up to Day 7

  • Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE

    Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method. The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

    Day 1 up to Day 7

  • Cumulative Dose of Open Label NE.

    Cumulative Dose of Open Label NE over 7 days. The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

    Day 1 up to Day 7

  • Infusion Rates of Open Label NE.

    Mean open label NE infusion rate within each predefined time period. The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.

    Day 1 up to Day 7

Secondary Outcomes (23)

  • Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration

    Day 1 up to Day 7

  • PK Parameter in Patients : Time to Steady State

    Day 1 up to Day 7

  • PK Parameter in Patients : Clearance

    Day 1 up to Day 7

  • PK Parameter in Patients : Steady State Volume of Distribution

    Day 1 up to Day 7

  • PK Parameter in Patients : Initial Elimination Half-life

    Day 1 up to Day 7

  • +18 more secondary outcomes

Study Arms (4)

FE 202158 1.25

EXPERIMENTAL

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Drug: FE 202158 1.25

FE 202158 2.5

EXPERIMENTAL

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Drug: FE 202158 2.5

FE 202158 3.75

EXPERIMENTAL

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.

Drug: FE 202158 3.75

PLCBO

PLACEBO COMPARATOR

Patients in the arm received an intravenous infusion for up to 7 days of placebo.

Other: Placebo

Interventions

FE 202158 1.25DRUG

FE 202158 at dose 1.25 ng/kg/min infused.

FE 202158 1.25
FE 202158 2.5DRUG

FE 202158 at dose 2.5 ng/kg/min infused.

FE 202158 2.5
FE 202158 3.75DRUG

FE 202158 at dose 3.75 ng/kg/min infused.

FE 202158 3.75
PlaceboOTHER

Isotonic saline infused.

PLCBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 randomized 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Christiana Care Health System

Newark, Delaware, United States

Location

Baystate Medical Center

Springfield, Massachusetts, United States

Location

Division of Education and Research SMDC Health System

Duluth, Minnesota, United States

Location

Cooper University Hospital

Camden, New Jersey, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

Clinique Universitaire St-Luc

Brussels, Belgium

Location

Erasme Hospital (Free University of Brussels)

Brussels, Belgium

Location

University Hospital Vrije Universiteit

Brussels, Belgium

Location

Service des Soins Intensits

Dinant, Belgium

Location

Royal Columbian Hospital

Vancouver, Canada

Location

St. Paul´s Hospital

Vancouver, Canada

Location

Bispebjerg Hospital

Bispebjerg, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hillerød Hospital

Hillerød, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Related Publications (2)

  • Russell JA, Vincent JL, Kjolbye AL, Olsson H, Blemings A, Spapen H, Carl P, Laterre PF, Grundemar L. Selepressin, a novel selective vasopressin V1A agonist, is an effective substitute for norepinephrine in a phase IIa randomized, placebo-controlled trial in septic shock patients. Crit Care. 2017 Aug 15;21(1):213. doi: 10.1186/s13054-017-1798-7.

    PMID: 28807037RESULT

  • Rehberg S, Yamamoto Y, Sousse L, Bartha E, Jonkam C, Hasselbach AK, Traber LD, Cox RA, Westphal M, Enkhbaatar P, Traber DL. Selective V(1a) agonism attenuates vascular dysfunction and fluid accumulation in ovine severe sepsis. Am J Physiol Heart Circ Physiol. 2012 Nov 15;303(10):H1245-54. doi: 10.1152/ajpheart.00390.2012. Epub 2012 Sep 7.

    PMID: 22961865DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Results Point of Contact

Title
Clinical Development Support
Organization
Ferring Pharmaceuticals
DK0-Disclosure@ferring.com

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 23, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

September 25, 2017

Results First Posted

June 2, 2017

Record last verified: 2017-08

Locations

BE(4)DK(4)CA(2)US(6)