NCT03119701: INFORAAA

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

Terminated Phase 2 Results posted Last updated 14 January 2021

What this trial tests

Phase 2 trial testing Interferon Beta-1A in Preventive Medicine in 40 participants. Terminated before completion.

Timeline

18 February 2017

Primary endpoint
23 September 2019

3 October 2019

Quick facts

Lead sponsor	Faron Pharmaceuticals Ltd
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	18 February 2017
Primary completion	23 September 2019
Estimated completion	3 October 2019
Sites	9 locations across Finland, Estonia, Lithuania

Drugs / interventions tested

• Interferon Beta-1A (INTERFERON BETA-1A) — full drug profile →
• Placebo

Conditions studied

• Preventive Medicine — all drugs for Preventive Medicine →
• Multi Organ Failure — all drugs for Multi Organ Failure →

Sponsor

Faron Pharmaceuticals Ltd — full company profile →

Who can join

18 and older, any sex, with Preventive Medicine or Multi Organ Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality Primary · Day 30

Number of fatalities

Group	Value	95% CI
FP-1201-lyo 10 µg	6
FP-1201-lyo Placebo	2

The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality Secondary · Day 90

Number of fatalities

Group	Value	95% CI
FP-1201-lyo 10 µg	7
FP-1201-lyo Placebo	2

The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs) Secondary · Day 30

Number of ventilator free days. VFDs to Day 30 were defined as the number of calendar days after initiating unassisted breathing (UAB) to Day 30 from first treatment, assuming that a patient survives at least 48 consecutive hours after initiating UAB. Patients who die without initiating UAB were assigned a VFD value of zero.

Group	Value	95% CI
FP-1201-lyo 10 µg	25.0	0.0 – 30.0
FP-1201-lyo Placebo	29.0	0.0 – 29.0

The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis Secondary · Day 30 and Day 90

Number of days receiving hemodialysis. There were only few reported values other than zero.

Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	0.9	± 4.15
FP-1201-lyo Placebo	0.0	± 0.00

Day 90

Group	Value	95% CI
FP-1201-lyo 10 µg	0.6	± 2.68
FP-1201-lyo Placebo	0.0	± 0.00

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 Secondary · Day 30

Organ failure free days were defined as the number of days in the first 30 days after the first dose of study medication that the patient was alive and free of organ failure with a SOFA score of zero for the following six organ parameters: respiration, coagulation, liver, cardiovascular, central nervous system and renal function. It is graded from 0 to 4 according to the degree of dysfunction/ failure (higher scores indicate more severe organ failure). Patients who died without achieving a SOFA score of zero was assigned an organ failure free days value of zero. Note: the information for orga

Group	Value	95% CI
FP-1201-lyo 10 µg	0.0	± 0.00
FP-1201-lyo Placebo	0.0	± 0.00

The Efficacy of FP-1201-lyo Compared to Placebo Concerning Prevalence of Abdominal Compartment Syndrome by Intra-abdominal Pressure (IAP) Secondary · Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay

Intra-abdominal pressure values, which were routinely measured during ICU stay via urine bladder catheter.

Day 1

Group	Value	95% CI
FP-1201-lyo 10 µg	15.4	± 12.37
FP-1201-lyo Placebo	10.3	± 4.80

Day 2

Group	Value	95% CI
FP-1201-lyo 10 µg	12.2	± 3.58
FP-1201-lyo Placebo	12.1	± 6.01

Day 3

Group	Value	95% CI
FP-1201-lyo 10 µg	13.1	± 4.62
FP-1201-lyo Placebo	10.3	± 5.35

Day 4

Group	Value	95% CI
FP-1201-lyo 10 µg	11.4	± 6.60
FP-1201-lyo Placebo	8.6	± 5.32

Day 5

Group	Value	95% CI
FP-1201-lyo 10 µg	10.5	± 3.14
FP-1201-lyo Placebo	12.5	± 5.45

Day 6

Group	Value	95% CI
FP-1201-lyo 10 µg	11.4	± 5.29
FP-1201-lyo Placebo	15.0	± 0

Day 9

Group	Value	95% CI
FP-1201-lyo 10 µg	11.0	± 5.48

Day 13

Group	Value	95% CI
FP-1201-lyo 10 µg	10.8	± 4.49

The Efficacy of FP-1201-lyo Compared to Placebo Concerning Neutralizing Antibodies Against IFN Beta-1a (NAbs) in Whole Blood Samples Secondary · Day 30

IFN beta-1a neutralizing antibodies immune response. Blood samples for the NAbs assessments were collected at Day 0 pre-dose (baseline) and at Day 30.

Baseline

Group	Value	95% CI
FP-1201-lyo 10 µg	0
FP-1201-lyo Placebo	0

Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	0
FP-1201-lyo Placebo	0

The Efficacy of FP-1201-lyo Compared to Placebo Concerning Disability by Modified Ranking Scale (mRS). Secondary · Day 90

Scale gives the degree of disability or dependence in the daily activities. Single mRS value is applied for every patient based on patient or caregiver interview. The scale runs from 0-6, from perfect health without symptoms to death. Pre-operation Baseline Visit mRS value is collected for reference.

No symptoms - 0

Group	Value	95% CI
FP-1201-lyo 10 µg	5
FP-1201-lyo Placebo	2

No significant disability - 1

Group	Value	95% CI
FP-1201-lyo 10 µg	5
FP-1201-lyo Placebo	5

Slight disability - 2

Group	Value	95% CI
FP-1201-lyo 10 µg	3
FP-1201-lyo Placebo	1

Moderate disability - 3

Group	Value	95% CI
FP-1201-lyo 10 µg	2
FP-1201-lyo Placebo	0

Moderately severe disability - 4

Group	Value	95% CI
FP-1201-lyo 10 µg	3
FP-1201-lyo Placebo	0

Severe disability - 5

Group	Value	95% CI
FP-1201-lyo 10 µg	2
FP-1201-lyo Placebo	1

Death - 6

Group	Value	95% CI
FP-1201-lyo 10 µg	7
FP-1201-lyo Placebo	2

Safety Parameters of Clinically Significant Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events, Vital Signs and Clinical Laboratory Parameters Secondary · Day 0 to Day 30

Number of TEAEs from vital signs data, laboratory data, physical examinations and spontaneous reporting when conscious.

Product-related TEAEs

Group	Value	95% CI
FP-1201-lyo 10 µg	17
FP-1201-lyo Placebo	1

Severe TEAEs

Group	Value	95% CI
FP-1201-lyo 10 µg	28
FP-1201-lyo Placebo	2

Serious TEAEs

Group	Value	95% CI
FP-1201-lyo 10 µg	26
FP-1201-lyo Placebo	5

TEAEs Leading to Study Product Discontinuation

Group	Value	95% CI
FP-1201-lyo 10 µg	7
FP-1201-lyo Placebo	1

TEAEs Leading to Death

Group	Value	95% CI
FP-1201-lyo 10 µg	7
FP-1201-lyo Placebo	1

Pharmacoeconomic Information of Length of ICU Stay, Length of Hospital Stay, Length of Stay at Another Health Care Facility, Length of Hemodialysis Needed, Ventilation Free Days Secondary · Day 30 or Day 90

Economic measurement: * Length of ICU stay, in terms of ICU free days at D30 * Length of hospital stay, in terms of hospital free days at D90 * Length of stay at another health care facility at D90 * The number of days on hemodialysis at D30 and at D90 * The number of organ failure free days at D30 * The number of ventilation free days at D30

ICU free days at Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	16.8	± 12.39
FP-1201-lyo Placebo	21.9	± 11.06

Days in hospital at Day 90

Group	Value	95% CI
FP-1201-lyo 10 µg	18.1	± 9.84
FP-1201-lyo Placebo	13.8	± 9.97

Days in another facility at Day 90

Group	Value	95% CI
FP-1201-lyo 10 µg	11.8	± 23.79
FP-1201-lyo Placebo	7.0	± 19.80

Days on hemodialysis at Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	0.9	± 4.15
FP-1201-lyo Placebo	0.0	± 0.00

Days on hemodialysis at Day 90

Group	Value	95% CI
FP-1201-lyo 10 µg	0.6	± 2.68
FP-1201-lyo Placebo	0.0	± 0.00

Organ failure free days at Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	0.0	± 0.00
FP-1201-lyo Placebo	0.0	± 0.00

Ventilation free days at Day 30

Group	Value	95% CI
FP-1201-lyo 10 µg	20.6	± 10.62
FP-1201-lyo Placebo	25.1	± 8.85

Myxovirus Resistant Protein A (MxA) Concentration in Whole Blood Samples as Pharmacodynamic Marker Secondary · Day 0 up to Day 13

Concentration of Myxovirus Resistant Protein A (MxA)

Baseline

Group	Value	95% CI
FP-1201-lyo 10 µg	3.5	2.4 – 5.1
FP-1201-lyo Placebo	6.0	3.3 – 11.0

Day 1

Group	Value	95% CI
FP-1201-lyo 10 µg	15.0	10.2 – 22.1
FP-1201-lyo Placebo	5.1	2.8 – 9.3

Day 2

Group	Value	95% CI
FP-1201-lyo 10 µg	19.8	13.5 – 29.1
FP-1201-lyo Placebo	3.8	2.1 – 7.0

Day 3

Group	Value	95% CI
FP-1201-lyo 10 µg	21.2	14.3 – 31.4
FP-1201-lyo Placebo	3.3	1.8 – 6.2

Day 4

Group	Value	95% CI
FP-1201-lyo 10 µg	36.4	24.4 – 54.2
FP-1201-lyo Placebo	4.1	2.2 – 7.7

Day 5

Group	Value	95% CI
FP-1201-lyo 10 µg	48.3	32.3 – 72.3
FP-1201-lyo Placebo	3.1	1.6 – 5.8

Day 6

Group	Value	95% CI
FP-1201-lyo 10 µg	50.4	33.9 – 75.1
FP-1201-lyo Placebo	3.6	1.9 – 6.8

Day 9

Group	Value	95% CI
FP-1201-lyo 10 µg	14.3	9.5 – 21.5
FP-1201-lyo Placebo	4.8	2.4 – 9.7

Tentative Disease Specific Marker Cluster of Differentiation 73 (CD73, Ecto-5'-Nucleotidase Enzyme) Concentration in Serum Samples Secondary · Day 0 up to Day 13

CD73 (ecto-5'-nucleotidase enzyme) concentration

Baseline

Group	Value	95% CI
FP-1201-lyo 10 µg	2.1	1.8 – 2.5
FP-1201-lyo Placebo	2.2	1.7 – 2.9

Day 1

Group	Value	95% CI
FP-1201-lyo 10 µg	2.0	1.7 – 2.4
FP-1201-lyo Placebo	2.2	1.6 – 2.8

Day 2

Group	Value	95% CI
FP-1201-lyo 10 µg	2.2	1.8 – 2.6
FP-1201-lyo Placebo	2.2	1.7 – 3.0

Day 3

Group	Value	95% CI
FP-1201-lyo 10 µg	2.0	1.7 – 2.4
FP-1201-lyo Placebo	2.3	1.7 – 3.1

Day 4

Group	Value	95% CI
FP-1201-lyo 10 µg	2.3	1.9 – 2.8
FP-1201-lyo Placebo	2.6	1.9 – 3.5

Day 5

Group	Value	95% CI
FP-1201-lyo 10 µg	3.0	2.4 – 3.6
FP-1201-lyo Placebo	3.5	2.6 – 4.8

Day 6

Group	Value	95% CI
FP-1201-lyo 10 µg	3.8	3.2 – 4.6
FP-1201-lyo Placebo	3.8	2.7 – 5.2

Day 9

Group	Value	95% CI
FP-1201-lyo 10 µg	3.9	3.2 – 4.8
FP-1201-lyo Placebo	3.8	2.6 – 5.4

Adverse events — posted to ClinicalTrials.gov

Time frame: The Adverse Event (AE) reporting period was up to study D30. In accordance with the protocol, the investigators reported AEs occurring after D30 only if the investigator considered a causal relationship with the study drug. All deaths were reported as SAEs throughout the study, up until D90.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FP-1201-lyo 10 µg

Serious: 13/29 (45%)

Deaths: 7/29

FP-1201-lyo Placebo

Serious: 3/11 (27%)

Deaths: 2/11

Serious adverse events (22 terms)

Reaction	System	FP-1201-lyo 10 µg	FP-1201-lyo Placebo
Multiple organ dysfunction syndrome	General disorders	—	—
Intestinal ischaemia	Gastrointestinal disorders	—	—
Large intestine perforation	Gastrointestinal disorders	—	—
Gastrointestinal necrosis	Gastrointestinal disorders	—	—
Myocardial ischaemia	Cardiac disorders	—	—
Gastric ulcer haemorrhage	Gastrointestinal disorders	—	—
Condition aggravated	General disorders	—	—
Anaphylactic reaction	Immune system disorders	—	—
Pneumonia	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Septic shock	Infections and infestations	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—
Pulmonary contusion	Injury, poisoning and procedural complications	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—
Sternal fracture	Injury, poisoning and procedural complications	—	—
Ischaemic cerebral infarction	Nervous system disorders	—	—
Paraplegia	Nervous system disorders	—	—
Spinal epidural haematoma	Nervous system disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (87 terms — click to expand)

Reaction	System	FP-1201-lyo 10 µg	FP-1201-lyo Placebo
Pyrexia	General disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Haemoglobin decreased	Investigations	—	—
Confusional state	Psychiatric disorders	—	—
Hypertension	Vascular disorders	—	—
Constipation	Gastrointestinal disorders	—	—
C-reactive protein increased	Investigations	—	—
Hepatic enzyme increased	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Hepatic failure	Hepatobiliary disorders	—	—
Candida infection	Infections and infestations	—	—
Device related infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Blood potassium decreased	Investigations	—	—
Liver function test abnormal	Investigations	—	—
Urine output decreased	Investigations	—	—
White blood cell count increased	Investigations	—	—
Anxiety	Psychiatric disorders	—	—
Delirium	Psychiatric disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Haemorrhagic anaemia	Blood and lymphatic system disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Tachycardia paroxysmal	Cardiac disorders	—	—
Eye irritation	Eye disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Chills	General disorders	—	—
Pain	General disorders	—	—
Systemic inflammatory response syndrome	General disorders	—	—
Catheter site infection	Infections and infestations	—	—
Clostridium difficile colitis	Infections and infestations	—	—

Most-reported serious reactions: Multiple organ dysfunction syndrome, Intestinal ischaemia, Large intestine perforation, Gastrointestinal necrosis, Myocardial ischaemia, Gastric ulcer haemorrhage, Condition aggravated, Anaphylactic reaction.

Data from ClinicalTrials.gov NCT03119701 adverse events section.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study.
   Hakovirta H, Jalkanen J, Saimanen E, Kukkonen T, et al · · 2022 · cited 6× · PMID 35115574 · DOI 10.1038/s41598-022-05771-1
2. CD73: agent development potential and its application in diabetes and atherosclerosis.
   Liu D, Zhao J, Li L, Wang J, et al · · 2024 · cited 2× · PMID 39735551 · DOI 10.3389/fimmu.2024.1515875
3. Targeting CD73 and correcting adenosinergic signaling in critically ill patients.
   Lunderberg JM, Spicer AJ, Cassavaugh J, Jalkanen J, et al · · 2025 · PMID 41601962 · DOI 10.3389/fphar.2025.1601481
4. Induction of CD73 Prevents Death after Emergency Open Aortic Surgery for a Ruptured Abdominal Aortic Aneurysm – A Randomized, Double-blind, Placebo-controlled Study
   Hakovirta H, Jalkanen J, Saimanen E, Kukkonen T, et al · · 2021 · DOI 10.21203/rs.3.rs-732466/v2