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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2014-003973-41-BE |
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Date of registration:
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03/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study to investigate the efficacy and safety of selepressin as treatment for patients with septic shock that need vasopressor treatment
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Scientific title:
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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 - SEPSIS-ACT |
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Date of first enrolment:
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22/06/2015 |
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Target sample size:
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1800 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003973-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: two-part adaptive clinical trial
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 5
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Denmark
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France
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Netherlands
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United States
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Contacts
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Name:
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Clinical Development Support
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Address:
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Kay Fiskers Plads 11
2300
Copenhagen S
Denmark |
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Telephone:
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Email:
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DK0-Disclosure@ferring.com |
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Affiliation:
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Ferring Pharmaceuticals A/S |
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Name:
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Clinical Development Support
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Address:
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Kay Fiskers Plads 11
2300
Copenhagen S
Denmark |
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Telephone:
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Email:
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DK0-Disclosure@ferring.com |
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Affiliation:
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Ferring Pharmaceuticals A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. 18 years of age or older.
2. Proven or suspected infection.
3. Septic shock defined as hypotension (systolic blood pressure less than 90 mmHg OR MAP less than 65 mmHg) requiring vasopressor treatment (i.e. any dose of norepinephrine / noradrenaline greater than 5 µg/min) despite adequate fluid resuscitation (at least one litre for hypotension).
4. Informed consent obtained in accordance with local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900
Exclusion criteria:
1. Not possible to initiate IMP treatment within 12 hours from onset of vasopressor treatment for septic shock.
2. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock).
3. Previous severe sepsis with ICU admission within this hospital stay.
4. Known/suspected acute mesenteric ischaemia.
5. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock.
6. 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.
7. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.
8. Known to be pregnant.
9. Decision to limit full care taken before obtaining informed consent.
10. Use of vasopressin in the past 12 hours prior to start of the IMP infusion or use of terlipressin within 7 days prior to start of the IMP infusion.
11. Prior enrolment in the trial.
12. 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:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Vasopressor-dependent Septic Shock
MedDRA version: 20.0
Level: PT
Classification code 10040070
Term: Septic shock
System Organ Class: 10021881 - Infections and infestations
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Intervention(s)
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Product Name: Selepressin
Product Code: FE 202158
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Selepressin
CAS Number: 876296-47-8
Current Sponsor code: FE 202158
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): Vassopressor- and mechanical ventilator-free days (P&VFDs) up to Day 30
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Main Objective: To demonstrate superiority of selepressin plus standard care versus placebo plus standard care in the number of vasopressor- and mechanical ventilator-free days (with penalty for mortality) in patients with vasopressor-dependent septic shock
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Secondary Objective: To determine the efficacy of selepressin on:
- Organ dysfunction
- Morbidity and mortality
- Fluid balance
- Health-related quality of life
To determine the safety profile of selepressin
To determine the pharmacokinetics of selepressin
To determine the health economics of selepressin
To further evaluate a range of biomarkers in relation to the mode of action of selepressin
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Timepoint(s) of evaluation of this end point: Up to day 30
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Continous assessment
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Secondary end point(s): - All-cause mortality (defined as the fraction of patients that have died, regardless of cause) at Day 90
- Renal replacement therapy (RRT)-free days up to Day 30 (excluding patients on RRT for chronic renal failure at time of randomisation)
- Intensive care unit (ICU)-free days up to Day 30
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Source(s) of Monetary Support
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Ferring Pharmaceuticals A/S
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Ethics review
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Status: Approved
Approval date: 22/06/2015
Contact:
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