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

• Status: Terminated
• Trial end date: 2019-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faron Pharmaceuticals Ltd
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

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