Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA

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

This trial is multicentre, randomised, double-blinded, Phase II, parallel group comparison study of the efficacy and safety of FP-1201-lyo compared to placebo in patients surviving emergency open surgery for an infra-renal ruptured abdominal aortic aneurysm. Investigational medicinal product will be administered as post-surgical preventive treatment either 10µg FP-1201-lyo or placebo. Treatment will be administered daily every 24 hrs for 6 days. The first dose will be given after successful surgery at the point when the patient arrives to the Intensive Care Unit (ICU).

Both treatment groups will receive standard supportive care.

Aim is randomise and initiate treatment of 152 patients. For the final analysis, a minimum of 129 evaluable patients will be required.

Eligibility 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 providing informed consent

   and
5. Age of 18 years or higher

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 Interferon (IFN) alpha or IFN beta
6. Dialysis therapy for chronic renal failure
7. Irreversible shock from haemorrhage
8. Unconsciousness or inability to give consent
9. Ruptured Endovascular Aortic Repair (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