Preventive MedicinePhase 2INFORAAANCT03119701
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 Phase 2 study testing Interferon Beta-1A in people with Preventive Medicine and Multi Organ Failure, run by Faron Pharmaceuticals Ltd at 9 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventive Medicine, Multi Organ Failure
- What is being tested?
- Interferon Beta-1A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 18 Feb 2017to 3 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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)
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- and
- Patients providing informed consent
- and
- Age of 18 years or higher
Who cannot join
- 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:
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Finland6 sites
Helsinki University Hospital
Helsinki, FI-00290
Central Finland Central Hospital
Jyväskylä, FI-40620
South Karelia Central Hospital
Lappeenranta, FI-53130
Oulu University Hospital
Oulu, FI-90220
Tampere University Hospital
Tampere, FI-33520
Turku University Hospital
Turku, FFI-20520
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, LT-50161
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661
About this study
Official title: A Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm
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
Read the 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
- Being tested
- Interferon Beta-1A, Placebo
- Keywords
- Patients Surviving Open Surgery, Ruptured Abdominal Aortic Aneurysm
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Beta-1ADrug
Also called FP-1201-lyo, ATC code L03AB07
Lyophilisate for solution for injection.
PlaceboDrug
Also called Placebo for investigational drug
Lyophilisate for solution for injection as placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
Number of fatalities
Measured: Day 30
Secondary outcomes (9)
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
Number of fatalities
Measured: Day 90
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs)
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.
Measured: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis
Number of days receiving hemodialysis. There were only few reported values other than zero.
Measured: 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
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 organ failure free days has been only collected when the patients have been in the Intensive Care Unit (ICU). As ICU free days have been reported in a separate variable, it was decided that presented information will be kept, without trying to conduct imputation.
Measured: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Prevalence of Abdominal Compartment Syndrome by Intra-abdominal Pressure (IAP)
Intra-abdominal pressure values, which were routinely measured during ICU stay via urine bladder catheter.
Measured: Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Neutralizing Antibodies Against IFN Beta-1a (NAbs) in Whole Blood Samples
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.
Measured: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Disability by Modified Ranking Scale (mRS).
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.
Measured: Day 90
Safety Parameters of Clinically Significant Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events, Vital Signs and Clinical Laboratory Parameters
Number of TEAEs from vital signs data, laboratory data, physical examinations and spontaneous reporting when conscious.
Measured: Day 0 to Day 30
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
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
Measured: Day 30 or Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start18 Feb 2017
- Primary completion23 Sep 2019
- Study completion3 Oct 2019
Why it stopped: IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faron Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harri Hakovirta, MD, Principal investigator, Turku University HospitalMaarit Venermo, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119701
- Sponsor's protocol ID
- FP1CLI006
- Other IDs
- 2014-000899-25, 2014
- Acronym
- INFORAAA
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2017
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35115574
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT03119701
- Acronym / sponsor ID
- INFORAAA / FP1CLI006
- Conditions
- Preventive Medicine, Multi Organ Failure
- Keywords
- Patients Surviving Open Surgery, Ruptured Abdominal Aortic Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faron Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FP-1201-lyo 10 µg | Experimental | Drug: Interferon Beta-1AFP-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. |
| FP-1201-lyo Placebo | Placebo comparator | Drug: PlaceboFP-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
- Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room
- 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)
Key exclusion criteria (19 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Beta-1AAlso: FP-1201-lyo, ATC code L03AB07Lyophilisate for solution for injection. | Drug | FP-1201-lyo 10 µg |
| PlaceboAlso: Placebo for investigational drugLyophilisate for solution for injection as placebo. | Drug | FP-1201-lyo Placebo |
Primary outcome
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
Time frame: Day 30
Number of fatalities
9 secondary outcomes
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
Time frame: Day 90
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs)
Time frame: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis
Time frame: 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
Time frame: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Prevalence of Abdominal Compartment Syndrome by Intra-abdominal Pressure (IAP)
Time frame: Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Neutralizing Antibodies Against IFN Beta-1a (NAbs) in Whole Blood Samples
Time frame: Day 30
The Efficacy of FP-1201-lyo Compared to Placebo Concerning Disability by Modified Ranking Scale (mRS).
Time frame: Day 90
Safety Parameters of Clinically Significant Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events, Vital Signs and Clinical Laboratory Parameters
Time frame: Day 0 to Day 30
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
Time frame: Day 30 or Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35115574Hakovirta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harri Hakovirta, MD principal investigator
Turku University Hospital
Maarit Venermo, MD principal investigator
Helsinki University Central Hospital
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon Beta-1A in people with Preventive Medicine and Multi Organ Failure, run by Faron Pharmaceuticals Ltd at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Finland, Lithuania, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03119701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.