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Traumakine for Multi-Organ Failure Prevention in RAAA
NCT03119701Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2017
- Primary completion
- Sep 2019
- Countries
- 3
- Sponsor
- Faron Pharmaceuticals
- Modality
- Cytokines & Interferons
- Drugs
- interferon beta-1a
- Conditions
- abdominal aortic aneurysm (AAA)
01
Overview
Phase 2, randomised, double-blind trial in abdominal aortic aneurysm (AAA) comparing Traumakine with Placebo (2 arms). Primary endpoint: All Cause Mortality at Day 30. Started Feb 2017; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Traumakine
FP-1201-lyo 10 µg IV daily for 6 days
Placebo
Placebo IV daily for 6 days
03
Who it enrols
Patients with ruptured abdominal aortic aneurysm (RAAA) undergoing open repair. Excludes those with moribund status, short life expectancy, NYHA IV heart failure, current IFN treatment, dialysis, irreversible shock, or cirrhosis.
04
Endpoints
Primary
All Cause Mortality
Secondary
All Cause Mortality
Number of Ventilator Free Days
Number of Days Receiving Hemodialysis
Number of Organ Failure Free Days (SOFA Score)
Prevalence of Abdominal Compartment Syndrome
Neutralizing Antibodies Against IFN Beta-1a
Disability by Modified Ranking Scale
Safety Parameters (TEAEs, SAEs, Vital Signs, Labs)
05
Results
Not all primary endpoints met
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