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

NCT02508649 | Terminated Phase 2 Results DMC

• 2 other identifiers: 0001332014-003973-41
• Study Type: interventional
• Target: 868
• Locations: 5 countries
• Sites: 21

Brief Summary

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Vasopressor- and Mechanical Ventilator-free Days (PVFDs)

  Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is: 1. Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation; 2. Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs; 3. Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs.

  Up to Day 30

Secondary Outcomes (19)

• All-cause Mortality

  At Day 90

• Renal Replacement Therapy (RRT)-Free Days

  Up to Day 30

• Intensive Care Unit (ICU)-Free Days

  Up to Day 30

• Vasopressor-free Days up to Day 30

  Up to Day 30

• Mechanical Ventilator-free Days up to Day 30

  Up to Day 30

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Selepressin 1

EXPERIMENTAL

Starting dose 1.7 ng/kg/min

Drug: selepressin

Selepressin 2

EXPERIMENTAL

Starting dose 2.5 ng/kg/min

Drug: selepressin

Selepressin 3

EXPERIMENTAL

Starting dose 3.5 ng/kg/min

Drug: selepressin

Selepressin 4

EXPERIMENTAL

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.

Drug: selepressin

Interventions

selepressin DRUG

Selepressin 1; Selepressin 2; Selepressin 3; Selepressin 4

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (21)

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, 83404, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northshore University Healthsystem Research Institute

Evanston, Illinois, 60201, United States

Location

Stormont Vail Health Care

Topeka, Kansas, 66604, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

HealthPartners Speciality Clinics

Saint Paul, Minnesota, 55101, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43210-1252, United States

Location

Remington Davis Inc

Columbus, Ohio, 43215, United States

Location

St Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

Cliniques Universitaires Saint-Luc (there may be other sites in this country)

Brussels, Belgium

Location

Aalborg Universitetshospital (there may be other sites in this country)

Aalborg, Denmark

Location

Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)

Limoges, France

Location

Radboud University Nijmegen Medical Centre (there may be other sites in this country)

Nijmegen, Netherlands

Location

Related Publications (2)

• Laterre PF, Berry SM, Blemings A, Carlsen JE, Francois B, Graves T, Jacobsen K, Lewis RJ, Opal SM, Perner A, Pickkers P, Russell JA, Windelov NA, Yealy DM, Asfar P, Bestle MH, Muller G, Bruel C, Brule N, Decruyenaere J, Dive AM, Dugernier T, Krell K, Lefrant JY, Megarbane B, Mercier E, Mira JP, Quenot JP, Rasmussen BS, Thorsen-Meyer HC, Vander Laenen M, Vang ML, Vignon P, Vinatier I, Wichmann S, Wittebole X, Kjolbye AL, Angus DC; SEPSIS-ACT Investigators. Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1476-1485. doi: 10.1001/jama.2019.14607.

  PMID: 31577035 DERIVED

• Lewis RJ, Angus DC, Laterre PF, Kjolbye AL, van der Meulen E, Blemings A, Graves T, Russell JA, Carlsen JE, Jacobsen K, Yealy DM, Opal SM, Windelov NA, Francois B, Perner A, Pickkers P, Berry SM. Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. Ann Am Thorac Soc. 2018 Feb;15(2):250-257. doi: 10.1513/AnnalsATS.201708-669SD.

  PMID: 29388815 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

+1 833-548-1402

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: October 3, 2017
• Study Completion: February 26, 2018
• Last Updated: April 6, 2021
• Results First Posted: April 6, 2021

Record last verified: 2020-09

Locations

NL (1); DK (1); US (17); BE (1); FR (1)