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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01000649 (opens ClinicalTrials.gov in a new tab)Other idFE 202158 CS02Other idEudraCT: 2009-010798-19
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
53 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Triple masking
Countries
4 countries

United States, Belgium, Canada, Denmark

Start
Nov 2009
Primary completion
Aug 2011
Completion
Sept 2011
First posted
23 Oct 2009 (estimated)
Last update posted
25 Sept 2017
Conditions
Septic Shock

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 2

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

    NCT01000649

    Nov 2009 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • FE 202158 1.25Drug
  • FE 202158 2.5Drug
  • FE 202158 3.75Drug
  • PlaceboOther

Arms4

  • Experimental

    FE 202158 1.25

    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.

  • Experimental

    FE 202158 2.5

    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.

  • Experimental

    FE 202158 3.75

    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.

  • Placebo comparator

    PLCBO

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

Primary outcomes4

Outcomes the sponsor listed as primary.

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

    Time frame · Day 1 up to Day 7

    Registry description

    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.

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

    Time frame · Day 1 up to Day 7

    Registry description

    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.

  3. Cumulative Dose of Open Label NE.

    Time frame · Day 1 up to Day 7

    Registry description

    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.

  4. Infusion Rates of Open Label NE.

    Time frame · Day 1 up to Day 7

    Registry description

    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.

Secondary outcomes(20)

  1. Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  2. PK Parameter in Patients : Time to Steady State

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  3. PK Parameter in Patients : Clearance

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  4. PK Parameter in Patients : Steady State Volume of Distribution

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  5. PK Parameter in Patients : Initial Elimination Half-life

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  6. PK Parameter in Patients : Terminal Elimination Half-life

    Time frame · Day 1 up to Day 7

    Registry description

    PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution. 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.

  7. Change From Baseline in C-reactive Protein (CRP)

    Time frame · Day 1 up to Day 7

    Registry description

    The change from Baseline in CRP levels were analysed and presented as per the planned time points. 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.

  8. Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha

    Time frame · At Day 1, Day 2, Day 4, and Day 7

    Registry description

    The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points. 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.

  9. Change From Baseline in Interleukin-6 (IL-6)

    Time frame · At Day 1, Day 2, Day 4, and Day 7

    Registry description

    The change from Baseline in IL-6 levels were analysed and presented as per the planned time points. 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.

  10. Change From Baseline in Interleukin-10 (IL-10)

    Time frame · At Day 1, Day 2, Day 4, and Day 7

    Registry description

    The change from Baseline in IL-10 levels were analysed and presented as per the planned time points. 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.

  11. Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist

    Time frame · At Day 1, Day 2, Day 4, and Day 7

    Registry description

    The change from Baseline in IL-1R levels were analysed and presented as per the planned time points. 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.

  12. Change From Baseline in Heart Rate

    Time frame · Day 1 up to Day 7

    Registry description

    The change from Baseline in heart rate was analysed and presented as per the planned time points. 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.

  13. Change From Baseline in Fluid Balance

    Time frame · Day 1 up to Day 7

    Registry description

    The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight. 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.

  14. SOFA Score

    Time frame · Day 1 up to Day 7, Day 14 and Day 29

    Registry description

    The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst). Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status. 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.

  15. Pulmonary Function : Change From Baseline in PaO2/FiO2

    Time frame · Day 1 up to Day 7

    Registry description

    Change from Baseline in PaO2/FiO2 was observed at each time-point. 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.

  16. Pulmonary Function : Change From Baseline in Tidal Volume

    Time frame · Day 1 up to Day 7

    Registry description

    Change from Baseline in tidal volume was observed at each time-point. 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.

  17. Change From Baseline in Arterial Blood Gas (Lactate)

    Time frame · Day 1 up to Day 7

    Registry description

    Change from Baseline in arterial blood gas (lactate) was observed at each time-point. 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.

  18. Days Alive and Free of Any Organ Dysfunction at Day 7

    Time frame · At Day 7

    Registry description

    Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7). 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.

  19. Percentage of Patients Alive and Free of All Vasopressors

    Time frame · At Day 7, Day 14 and Day 28

    Registry description

    Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28. 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.

  20. Percentage of Days Alive and Free of Dialysis

    Time frame · At Day 7, Day 14 and Day 28

    Registry description

    Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28. 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1 up to Day 7

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

GroupValue (Percentage of patients)
FE 202158 1.250.0
FE 202158 2.547.1
PLCBO0.0
Primary outcomeNumber· Day 1 up to Day 7

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

GroupValue (Percentage of patients)
FE 202158 1.25100.0
FE 202158 2.5100.0
PLCBO94.7
Primary outcomeMean· Day 1 up to Day 7

Cumulative Dose of Open Label NE.

GroupValue (µg/kg)Spread
FE 202158 1.2514.311.6
FE 202158 2.513.112.6
PLCBO19.214.6
Secondary and other outcome results(5)
Secondary outcomeMean· Day 1 up to Day 7

Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration

GroupValue (ng/mL)Spread
FE 202158 1.250.500.13
FE 202158 2.50.990.32
Secondary outcomeMean· Day 1 up to Day 7

PK Parameter in Patients : Time to Steady State

GroupValue (Hour)Spread
FE 202158 1.257.62.8
FE 202158 2.57.02.3
Secondary outcomeMean· Day 1 up to Day 7

PK Parameter in Patients : Clearance

GroupValue (Litre/hour)Spread
FE 202158 1.2510.02.8
FE 202158 2.513.12.9
Secondary outcomeMean· Day 1 up to Day 7

PK Parameter in Patients : Steady State Volume of Distribution

GroupValue (Litre)Spread
FE 202158 1.2525.510.6
FE 202158 2.531.214.7
Secondary outcomeMean· Day 1 up to Day 7

PK Parameter in Patients : Initial Elimination Half-life

GroupValue (Hour)Spread
FE 202158 1.250.180.09
FE 202158 2.50.170.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FE 202158 1.25Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days. 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.–2 / 106 / 10
FE 202158 2.5Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days. 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.–2 / 1914 / 19
FE 202158 3.75Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days. 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.–2 / 20 / 2
PLCBOPatients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.–6 / 2113 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

9 results

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.

Russell et al. 2017Critical care (London, England)cited by 77

PMID 28807037PMC5557574DOI 10.1186/s13054-017-1798-7PUB-28807037

CC BY9 results
Download PDFSee results (9)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedRehberg 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 22961865

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 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 * Considered by the investigator to be unsuitable to participate in the trial for any other reason

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