Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial (SEPSIS-ACT)
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| ClinicalTrials.gov Identifier: NCT02508649 |
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Recruitment Status :
Terminated
(Terminated due to futility)
First Posted : July 27, 2015
Last Update Posted : March 5, 2019
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Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Septic Shock | Drug: selepressin Drug: placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 868 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | July 2015 |
| Actual Primary Completion Date : | October 3, 2017 |
| Actual Study Completion Date : | February 26, 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo |
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Experimental: Selepressin 1
Starting dose 1.7 ng/kg/min
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Drug: selepressin |
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Experimental: Selepressin 2
Starting dose 2.5 ng/kg/min
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Drug: selepressin |
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Experimental: Selepressin 3
Starting dose 3.5 ng/kg/min
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Drug: selepressin |
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Experimental: Selepressin 4
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 |
Primary Outcome Measures :
- Vasopressor- and mechanical ventilator-free days [ Time Frame: Up to Day 30 ]This composite endpoint is defined as number of days from start of treatment to 30 days thereafter during which the patient is 1) alive; 2) free of treatment with vasopressors; 3) free of any mechanical ventilation
Secondary Outcome Measures :
- All-cause mortality [ Time Frame: At Day 90 ]Defined as the fraction of patients that have died
- Renal replacement therapy-free days [ Time Frame: Up to Day 30 ]
- Intensive care unit-free days [ Time Frame: Up to Day 30 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508649
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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02508649 History of Changes |
| Other Study ID Numbers: |
000133 2014-003973-41 ( EudraCT Number ) |
| First Posted: | July 27, 2015 Key Record Dates |
| Last Update Posted: | March 5, 2019 |
| Last Verified: | March 2019 |
Additional relevant MeSH terms:
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Shock, Septic Shock Pathologic Processes Sepsis |
Infection Systemic Inflammatory Response Syndrome Inflammation |