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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02508649
First received: July 17, 2015
Last updated: August 29, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Septic Shock Drug: selepressin Drug: placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 1800
Actual Study Start Date: July 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received: July 17, 2015
Last Updated: August 29, 2017

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

ClinicalTrials.gov processed this record on September 20, 2017