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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02508649
Recruitment Status : Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: selepressin Drug: placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 868 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2015
Primary Completion Date : October 3, 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
Experimental: Selepressin 1
Starting dose 1.7 ng/kg/min
Drug: selepressin
Experimental: Selepressin 2
Starting dose 2.5 ng/kg/min
Drug: selepressin
Experimental: Selepressin 3
Starting dose 3.5 ng/kg/min
Drug: selepressin
Experimental: Selepressin 4
Starting dose 5.0 ng/kg/min
Drug: selepressin


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: At Day 90 ]
    Defined as the fraction of patients that have died

  2. Renal replacement therapy-free days [ Time Frame: Up to Day 30 ]
  3. Intensive care unit-free days [ Time Frame: Up to Day 30 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508649


  Show 26 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02508649     History of Changes
Other Study ID Numbers: 000133
2014-003973-41 ( EudraCT Number )
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

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