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Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial (SEPSIS-ACT)

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ClinicalTrials.gov Identifier: NCT02508649
Recruitment Status : Terminated (Terminated due to futility)
First Posted : July 27, 2015
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 27, 2015
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
Vasopressor- and mechanical ventilator-free days [ Time Frame: Up to Day 30 ]
This composite endpoint is defined as number of days from start of treatment to 30 days thereafter during which the patient is 1) alive; 2) free of treatment with vasopressors; 3) free of any mechanical ventilation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • All-cause mortality [ Time Frame: At Day 90 ]
    Defined as the fraction of patients that have died
  • Renal replacement therapy-free days [ Time Frame: Up to Day 30 ]
  • Intensive care unit-free days [ Time Frame: Up to Day 30 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • All-cause mortality [ Time Frame: At Day 90 ]
    Defined as the fraction of patients that have died
  • Renal replacement treatment-free days [ Time Frame: Up to Day 30 ]
  • Intensive care unit-free days [ Time Frame: Up to Day 30 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
Official Title  ICMJE A Double-blind, Randomised, Placebo-Controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients With Vasopressor-dependent Septic Shock
Brief Summary This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE
  • Drug: selepressin
  • Drug: placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Selepressin 1
    Starting dose 1.7 ng/kg/min
    Intervention: Drug: selepressin
  • Experimental: Selepressin 2
    Starting dose 2.5 ng/kg/min
    Intervention: Drug: selepressin
  • Experimental: Selepressin 3
    Starting dose 3.5 ng/kg/min
    Intervention: Drug: selepressin
  • Experimental: Selepressin 4

    Starting dose 5.0 ng/kg/min

    The highest dosing regimen of selepressin was not investigated in the trial as the desired primary outcome for selepressin 3 arm was not achieved, and the trial was terminated for futility.

    Intervention: Drug: selepressin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2017)
868
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2015)
1800
Actual Study Completion Date  ICMJE February 26, 2018
Actual Primary Completion Date October 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Proven or suspected infection
  • Septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation
  • Informed consent obtained in accordance with local regulations

Exclusion Criteria:

  • Not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock
  • Primary cause of hypotension not due to sepsis
  • Previous severe sepsis with intensive care unit admission within this hospital stay
  • Known/suspected acute mesenteric ischaemia
  • Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock
  • Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days
  • Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
  • Known to be pregnant
  • Decision to limit full care taken before obtaining informed consent
  • Use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment
  • Prior enrolment in the trial
  • Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02508649
Other Study ID Numbers  ICMJE 000133
2014-003973-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP