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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000899-25 | EudraCT Number |
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IDMC recommendation. Unexpectedly high use of concomitant corticosteroid treatment.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon Beta-1A | Drug | Lyophilisate for solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality | Number of fatalities | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality | Number of fatalities | Day 90 |
| The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs) |
| Measure | Description | Time Frame |
|---|---|---|
| Myxovirus Resistant Protein A (MxA) Concentration in Whole Blood Samples as Pharmacodynamic Marker | Concentration of Myxovirus Resistant Protein A (MxA) | Day 0 up to Day 13 |
| Tentative Disease Specific Marker Cluster of Differentiation 73 (CD73, Ecto-5'-Nucleotidase Enzyme) Concentration in Serum Samples |
Inclusion Criteria:
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)
and
Patients providing informed consent
and
Age of 18 years or higher
Exclusion Criteria:
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
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
Note:
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| Name | Affiliation | Role |
|---|---|---|
| Harri Hakovirta, MD | Turku University Hospital | Principal Investigator |
| Maarit Venermo, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | 51014 | Estonia | |||
| Helsinki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35115574 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FP-1201-lyo 10 µg | FP-1201-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. Interferon Beta-1a: investigational drug. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 6-day Dosing |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2019 | Sep 21, 2020 |
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.
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| Placebo | Drug | Lyophilisate for solution for injection as placebo. |
|
|
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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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:
| Day 30 or Day 90 |
CD73 (ecto-5'-nucleotidase enzyme) concentration |
| Day 0 up to Day 13 |
| Tentative Disease Specific, Potential Inflammatory Marker - Interleukin 6 (IL-6) in Serum Samples | IL-6 concentration. | Day 0 up to Day 13 |
| Tentative Disease Specific, Potential Inflammatory Marker - Hepatocyte Growth Factor [HGF]) in Serum Samples | HGF concentration. | Day 0 up to Day 13 |
| Helsinki |
| FI-00290 |
| Finland |
| Central Finland Central Hospital | Jyväskylä | FI-40620 | Finland |
| South Karelia Central Hospital | Lappeenranta | FI-53130 | Finland |
| Oulu University Hospital | Oulu | FI-90220 | Finland |
| Tampere University Hospital | Tampere | FI-33520 | Finland |
| Turku University Hospital | Turku | FFI-20520 | Finland |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | LT-50161 | Lithuania |
| Vilnius University Hospital Santaros klinikos | Vilnius | LT-08661 | Lithuania |
| 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 Placebo: placebo for investigational drug. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Mid-term (Final) Follow-up at D90 |
|
|
A total of 40 subjects received at least 1 dose of study drug. 2 patients were excluded from Full Analysis Set for Efficacy (FAS-E) and Per Protocol Set (PPS) populations due to early deaths (within 36 hours from first dose of the study treatment). Therefore, FAS-E and PPS populations consisted of 38 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | FP-1201-lyo 10 µg | FP-1201-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. Interferon Beta-1a: investigational drug. |
| BG001 | 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 Placebo: placebo for Investigational drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Baseline Height | Mean | Standard Deviation | centimetres |
| |||||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality | Number of fatalities | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality | Number of fatalities | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). | Posted | Count of Participants | Participants | Day 90 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). | Posted | Median | Full Range | days | Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure. | Posted | Mean | Standard Deviation | days | Day 30 and Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). | Posted | Mean | Standard Deviation | days | Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). The number of participants analyzed reflects the number of patients that were alive and had sufficient data to allow for calculation of the outcome measure. | Posted | Mean | Standard Deviation | mmHg | Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | At the Baseline Visit, 2 patients in the FP-1201-lyo treatment group and 1 patient in the placebo treatment group were not tested for anti-drug antibodies. | Posted | Count of Participants | Participants | Day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). | Posted | Count of Participants | Participants | Day 90 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set for Safety (FAS-S) consisted of all randomised patients receiving study treatment and comprised the analysis set on which the evaluation of safety is based. | Posted | Number | Events | Day 0 to Day 30 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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:
| The Full Analysis Set for Efficacy (FAS-E). As the study was discontinued, analyses were performed on the available data gathered thus far. | Posted | Mean | Standard Deviation | days | Day 30 or Day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Myxovirus Resistant Protein A (MxA) Concentration in Whole Blood Samples as Pharmacodynamic Marker | Concentration of Myxovirus Resistant Protein A (MxA) | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). The overall number of participants analyzed reflects the number of patients that were alive and had data to allow for calculation of the outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 0 up to Day 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tentative Disease Specific Marker Cluster of Differentiation 73 (CD73, Ecto-5'-Nucleotidase Enzyme) Concentration in Serum Samples | CD73 (ecto-5'-nucleotidase enzyme) concentration | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). The overall number of participants analyzed reflects the number of patients that were alive and had data to allow for calculation of the outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 0 up to Day 13 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tentative Disease Specific, Potential Inflammatory Marker - Interleukin 6 (IL-6) in Serum Samples | IL-6 concentration. | The Full Analysis Set for Efficacy (FAS-E) defined as all randomised patients who received study treatment, excluding the early deaths (within 36 hours from first dose of the study treatment). The overall number of participants analyzed reflects the number of patients that were alive and had data to allow for calculation of the outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Day 0 up to Day 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tentative Disease Specific, Potential Inflammatory Marker - Hepatocyte Growth Factor [HGF]) in Serum Samples | HGF concentration. | Data were not collected or analyzed due to the small groups and interference of corticosteroids it was not meaningful to perform the analyzes. | Posted | Day 0 up to Day 13 |
|
|
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.
The "Serious Adverse Event" list and the "Other (Not including Serious) Adverse Event" list present all reported Treatment Emergent Adverse Events (defined as an AE that begins or that worsens in severity after at least one dose of study drug). In 3 study subjects a non-treatment emergent SAE began before first dose of the study drug (included in mortality numbers because these SAEs led to death)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FP-1201-lyo 10 µg | FP-1201-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. Interferon Beta-1a: investigational drug. | 7 | 29 | 13 | 29 | 27 | 29 |
| EG001 | 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 Placebo: placebo for investigational drug. | 2 | 11 | 3 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal epidural haematoma | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Post procedural constipation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Postoperative delirium | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Inflammatory marker increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Intra-abdominal pressure increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
The study was prematurely stopped and due to this the planned statistical power for the primary comparisons was not reached.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Faron Pharmaceuticals Ltd | +3584005529411 | medical@faron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2019 | Sep 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| D015507 | Drugs, Investigational |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| > 80 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Lithuania |
|
| Estonia |
|
|
|
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| 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 Placebo: placebo for investigational drug. |
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