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

NCT03119701 | Terminated Phase 2 Results DMC

• 2 other identifiers: FP1CLI0062014-000899-25
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 9

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

Conditions

Preventive Medicine; Multi Organ Failure

Keywords

Patients Surviving Open Surgery; Ruptured Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality

  Number of fatalities

  Day 30

Secondary Outcomes (9)

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality

  Day 90

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs)

  Day 30

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis

  Day 30 and Day 90

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Organ Failure Free Days by Means of the Sequential Organ Failure Assessment (SOFA) Score

  Day 30

• The Efficacy of FP-1201-lyo Compared to Placebo Concerning Prevalence of Abdominal Compartment Syndrome by Intra-abdominal Pressure (IAP)

  Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay

Other Outcomes (4)

• Myxovirus Resistant Protein A (MxA) Concentration in Whole Blood Samples as Pharmacodynamic Marker

  Day 0 up to Day 13

• Tentative Disease Specific Marker Cluster of Differentiation 73 (CD73, Ecto-5'-Nucleotidase Enzyme) Concentration in Serum Samples

  Day 0 up to Day 13

• Tentative Disease Specific, Potential Inflammatory Marker - Interleukin 6 (IL-6) in Serum Samples

  Day 0 up to Day 13

Study Arms (2)

FP-1201-lyo 10 µg

EXPERIMENTAL

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.

Drug: Interferon Beta-1A

FP-1201-lyo Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Interferon Beta-1A DRUG

Lyophilisate for solution for injection.

Also known as: FP-1201-lyo, ATC code L03AB07

FP-1201-lyo 10 µg

Placebo DRUG

Lyophilisate for solution for injection as placebo.

Also known as: Placebo for investigational drug

FP-1201-lyo Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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
• Patients providing informed consent
• and
• Age of 18 years or higher

You may not qualify if:

• Moribund patient not eligible for treatment in ICU or expected to survive surgery
• Markedly short life expectancy, e.g. advanced malignant disease
• Current participation in another experimental treatment protocol
• Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV
• Current treatment with Interferon (IFN) alpha or IFN beta
• Dialysis therapy for chronic renal failure
• Irreversible shock from haemorrhage
• Unconsciousness or inability to give consent
• Ruptured Endovascular Aortic Repair (rEVAR) first (prior attempt for endovascular aortic repair for the current rupture)
• Diagnosed cirrhosis
• Pregnancy and women with child bearing potential without negative pregnancy test
• Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded)
• RAAA requiring repair of the renal arteries or the proximal aorta
• thoracoabdominal aneurysms requiring immediate repair
• damaged renal arteries during emergency clamping requiring repair

Sponsors & Collaborators

• Faron Pharmaceuticals Ltd: lead

Study Sites (9)

Tartu University Hospital

Tartu, 51014, Estonia

Location

Helsinki University Hospital

Helsinki, FI-00290, Finland

Location

Central Finland Central Hospital

Jyväskylä, FI-40620, Finland

Location

South Karelia Central Hospital

Lappeenranta, FI-53130, Finland

Location

Oulu University Hospital

Oulu, FI-90220, Finland

Location

Tampere University Hospital

Tampere, FI-33520, Finland

Location

Turku University Hospital

Turku, FFI-20520, Finland

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, LT-50161, Lithuania

Location

Vilnius University Hospital Santaros klinikos

Vilnius, LT-08661, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 35115574 DERIVED

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

Interferon beta-1a; Drugs, Investigational

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pharmaceutical Preparations

Limitations and Caveats

The study was prematurely stopped and due to this the planned statistical power for the primary comparisons was not reached.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Faron Pharmaceuticals Ltd

medical@faron.com

+3584005529411

Study Officials

• Harri Hakovirta, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Maarit Venermo, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 19, 2017
• Study Start: February 18, 2017
• Primary Completion: September 23, 2019
• Study Completion: October 3, 2019
• Last Updated: January 14, 2021
• Results First Posted: January 14, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2); ES (1); FI (6)