Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm. MedDRA version: 20.0 Level: LLT Classification code 10028154 Term: Multi-organ failure System Organ Class: 100000004867
Conditions
Sponsors
Faron Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria during screening and prior to the first dose of study medication being administered on D0 (criteria 1 or 2 and all 3, 4 and 5): 1. Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room • all forms of infrarenal RAAAs with or without coexisting iliac aneurysms are included or 2. Patients (male or female) presenting with symptoms of RAAA known to have an infrarenal AAA and proceeding straight to open repair without radiological assessment and confirmed rupture (=retroperitoneal haematoma) in operation and 3. Aneurysma repair must be infra-renal, i.e. the proximal anastomosis must be below the renal arteries and the renal arteries have to stay intact. Temporary above the renal clamping can be used for a maximum of 30 minutes (total clamping time) and 4. Patients or their next of kin providing informed consent (written signed or witnessed) and 5. Age of 18 years or higher 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 137
Exclusion criteria
Exclusion criteria: To be eligible for inclusion into this study, each patient must not meet any of the following exclusion criteria during screening or prior to the first dose of study medication being administered: 1. Moribund patient not eligible for treatment in ICU or expected to survive surgery 2. Markedly short life expectancy, e.g. advanced malignant disease 3. Current participation in another experimental treatment protocol 4. Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV 5. Current treatment with IFN alpha or IFN beta 6. Dialysis therapy for chronic renal failure 7. Irreversible shock from haemorrhage 8. Unconsciousness when arriving to the hospital and during screening 9. rEVAR first (prior attempt for endovascular aortic repair for the current rupture) 10. Diagnosed cirrhosis 11. Pregnancy and women with child bearing potential without negative pregnancy test 12. Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded) 13. RAAA requiring repair of the renal arteries or the proximal aorta • thoracoabdominal aneurysms requiring immediate repair • damaged renal arteries during emergency clamping requiring repair NOTE: • temporary clamping above the renal arteries (max 30 min total clamping time above the renal arteries) does not lead to exclusion • ligation of the left renal vein does not lead to exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of FP-1201-lyo over placebo on all-cause mortality at study day 30; D30 .; Secondary Objective: 1. To evaluate the efficacy of FP-1201-lyo treatment by assessing short term outcomes (D30) and midterm outcomes (D90 [3 months]) 2. To evaluate the safety and tolerability of FP-1201-lyo treatment 3. To evaluate the pharmacodynamics (PD) of FP-1201-lyo 4. To evaluate the Tentative Disease Specific Marker CD73 and Potential Inflammatory Markers (PIM) 5. To evaluate neutralizing antibodies against IFN beta-1a (NAbs) ; Primary end point(s): Primary Efficacy Endpoint: • All cause mortality at D30 ;Timepoint(s) of evaluation of this end point: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Days 0-13, Day 30, Day 90 ; Secondary end point(s): Secondary Efficacy Endpoints: • All cause mortality at D90 (3 months) • Number of ventilator free days (VFDs) at D30 • Number of days receiving haemodialysis at D30 and D90 • Number of organ failure free days up to D30 by means of the SOFA score • Prevalence of abdominal compartment syndrome, i.e. intra-abdominal pressure (IAP) between study groups • Neutralizing antibodies against IFN beta-1a (NAbs) in whole blood samples up to D30 • Disability on D90 measured by modified ranking scale (mRS) Safety: • Clinically significant treatment emergent adverse events (TEAEs) up to D30 from vital signs data, laboratory data, physical examinations and spontaneous reporting when conscious Pharmacoeconomics: • Length of ICU stay, in terms of ICU free days at D30 • Length of hospital stay, in terms of hospital free days at D90 • Length of stay at another health care facility at D90 • Length of haemodialysis needed • Ventilation free days at D30 Pharmacodynamics (PD): • MxA (protein) concentration in whole blood samples from baseline up to D13 Tentative Disease Specific Marker: • CD73 concentration/activity in serum samples from baseline up to D13 • Potential Inflammatory Markers (IL-6 and HGF) in serum samples from baseline up to D13 | — |
Countries
Estonia, Finland, Lithuania, United Kingdom
Contacts
Public ContactCMO, VP Drug Development
Faron Pharmaceuticals Ltd
Outcome results
None listed