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

NCT ID: NCT03119701

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-18
• Study Completion Date: 2019-10-03

Brief 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

Detailed Description

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.

Conditions

Preventive Medicine; Multi Organ Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

FP-1201-lyo 10 µg

FP-12-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.

Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.

Group Type: EXPERIMENTAL

Interferon Beta-1A

Intervention Type: DRUG

Lyophilisate for solution for injection.

FP-1201-lyo Placebo

FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.

Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Lyophilisate for solution for injection as placebo.

Interventions

Interferon Beta-1A

Lyophilisate for solution for injection.

Intervention Type: DRUG

Placebo

Lyophilisate for solution for injection as placebo.

Intervention Type: DRUG

Other Intervention Names

FP-1201-lyo; ATC code L03AB07; Placebo for investigational drug

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faron Pharmaceuticals Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harri Hakovirta, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Maarit Venermo, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Tartu University Hospital

Tartu, , Estonia

Helsinki University Hospital

Helsinki, , Finland

Central Finland Central Hospital

Jyväskylä, , Finland

South Karelia Central Hospital

Lappeenranta, , Finland

Oulu University Hospital

Oulu, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

Vilnius University Hospital Santaros klinikos

Vilnius, , Lithuania

Countries

Estonia; Finland; Lithuania

References

Hakovirta H, Jalkanen J, Saimanen E, Kukkonen T, Romsi P, Suominen V, Vikatmaa L, Valtonen M, Karvonen MK, Venermo M; INFORAAA Study Group. Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study. Sci Rep. 2022 Feb 3;12(1):1839. doi: 10.1038/s41598-022-05771-1.

Reference Type: DERIVED

PMID: 35115574 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-000899-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FP1CLI006

Identifier Type: -

Identifier Source: org_study_id