A study to assess effectiveness and safety of a drug FP-1201-lyo (recombinant human interferon beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery for a Ruptured Abdominal Aortic Aneurysm

Phase 1

Conditions: 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
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-000899-25-FI

Lead Sponsor: Faron Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 152

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of FP-1201-lyo over placebo on all-cause mortality at study day 30; D30 .;<br> Secondary Objective: 1. To evaluate the efficacy of FP-1201-lyo treatment by assessing short term outcomes (D30) and midterm outcomes (D90 [3 months])<br> 2. To evaluate the safety and tolerability of FP-1201-lyo treatment<br> 3. To evaluate the pharmacodynamics (PD) of FP-1201-lyo<br> 4. To evaluate the Tentative Disease Specific Marker CD73 and Potential Inflammatory Markers (PIM)<br> 5. To evaluate neutralizing antibodies against IFN beta-1a (NAbs)<br> ;<br> Primary end point(s): Primary Efficacy Endpoint:<br> • All cause mortality at D30<br> ;Timepoint(s) of evaluation of this end point: Day 30

Secondary Outcome Measures

Name	Time	Method

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