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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02508649
• Date of registration: 17/07/2015
• Prospective Registration: No
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial SEPSIS-ACT
• Scientific 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
• Date of first enrolment: July 2015
• Target sample size: 868
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02508649
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Belgium, Denmark, France, Netherlands, United States

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Septic Shock

Intervention(s)

Drug: placebo

Drug: selepressin

Primary Outcome(s)

Vasopressor- and mechanical ventilator-free days [Time Frame: Up to Day 30]

Secondary Outcome(s)

All-cause mortality [Time Frame: At Day 90]

Renal replacement therapy-free days [Time Frame: Up to Day 30]

Intensive care unit-free days [Time Frame: Up to Day 30]

Secondary ID(s)

2014-003973-41

000133

Source(s) of Monetary Support

Please refer to primary and secondary sponsors