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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT02508649

Run by

Ferring Pharmaceuticals

People needed

868

Starts

2015-07-01

Expected to finish

2018-02-26

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Hospital — Colorado Springs, Colorado, United States
• Eastern Idaho Regional Medical Center — Idaho Falls, Idaho, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Northshore University Healthsystem Research Institute — Evanston, Illinois, United States
• Stormont Vail Health Care — Topeka, Kansas, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• HealthPartners Speciality Clinics — Saint Paul, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Remington Davis Inc — Columbus, Ohio, United States
• St Vincent Mercy Medical Center — Toledo, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Cliniques Universitaires Saint-Luc (there may be other sites in this country) — Brussels, Belgium
• Aalborg Universitetshospital (there may be other sites in this country) — Aalborg, Denmark
• Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country) — Limoges, France
• Radboud University Nijmegen Medical Centre (there may be other sites in this country) — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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