Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial

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

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.

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