Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA (INFORAAA)
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|ClinicalTrials.gov Identifier: NCT03119701|
Recruitment Status : Terminated (IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.)
First Posted : April 19, 2017
Results First Posted : January 14, 2021
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Preventive Medicine Multi Organ Failure||Drug: Interferon Beta-1A Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||February 18, 2017|
|Actual Primary Completion Date :||September 23, 2019|
|Actual Study Completion Date :||October 3, 2019|
Experimental: 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.
Drug: Interferon Beta-1A
Lyophilisate for solution for injection.
Placebo Comparator: 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
Lyophilisate for solution for injection as placebo.
Other Name: Placebo for investigational drug
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality [ Time Frame: Day 30 ]Number of fatalities
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality [ Time Frame: Day 90 ]Number of fatalities
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs) [ Time Frame: 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.
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis [ Time Frame: Day 30 and Day 90 ]Number of days receiving hemodialysis. There were only few reported values other than zero.
- 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 ]
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.
- 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 ]Intra-abdominal pressure values, which were routinely measured during ICU stay via urine bladder catheter.
- 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 ]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.
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Disability by Modified Ranking Scale (mRS). [ Time Frame: 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.
- 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 ]Number of TEAEs from vital signs data, laboratory data, physical examinations and spontaneous reporting when conscious.
- 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 ]
- 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
- Myxovirus Resistant Protein A (MxA) Concentration in Whole Blood Samples as Pharmacodynamic Marker [ Time Frame: Day 0 up to Day 13 ]Concentration of Myxovirus Resistant Protein A (MxA)
- Tentative Disease Specific Marker Cluster of Differentiation 73 (CD73, Ecto-5'-Nucleotidase Enzyme) Concentration in Serum Samples [ Time Frame: Day 0 up to Day 13 ]CD73 (ecto-5'-nucleotidase enzyme) concentration
- Tentative Disease Specific, Potential Inflammatory Marker - Interleukin 6 (IL-6) in Serum Samples [ Time Frame: Day 0 up to Day 13 ]IL-6 concentration.
- Tentative Disease Specific, Potential Inflammatory Marker - Hepatocyte Growth Factor [HGF]) in Serum Samples [ Time Frame: Day 0 up to Day 13 ]HGF concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119701
|Tartu University Hospital|
|Tartu, Estonia, 51014|
|Helsinki University Hospital|
|Helsinki, Finland, FI-00290|
|Central Finland Central Hospital|
|Jyväskylä, Finland, FI-40620|
|South Karelia Central Hospital|
|Lappeenranta, Finland, FI-53130|
|Oulu University Hospital|
|Oulu, Finland, FI-90220|
|Tampere University Hospital|
|Tampere, Finland, FI-33520|
|Turku University Hospital|
|Turku, Finland, FFI-20520|
|Hospital of Lithuanian University of Health Sciences Kauno klinikos|
|Kaunas, Lithuania, LT-50161|
|Vilnius University Hospital Santaros klinikos|
|Vilnius, Lithuania, LT-08661|
|Principal Investigator:||Harri Hakovirta, MD||Turku University Hospital|
|Principal Investigator:||Maarit Venermo, MD||Helsinki University Central Hospital|