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

Ferring

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Septic Shock

Treatments: Drug: selepressin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02508649

000133

2014-003973-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 868 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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868 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Selepressin 1

Experimental group

Description:

Starting dose 1.7 ng/kg/min

Treatment:

Drug: selepressin

Selepressin 2

Experimental group

Description:

Starting dose 2.5 ng/kg/min

Treatment:

Drug: selepressin

Selepressin 3

Experimental group

Description:

Starting dose 3.5 ng/kg/min

Treatment:

Drug: selepressin

Selepressin 4

Experimental group

Description:

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.

Treatment:

Drug: selepressin