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This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.
This was a randomised, double-blind, two-stage, placebo-controlled study. It was composed of 2 stages with a similar treatment regimen in which 0.3, 1.0 or 3.0 mg/kg/h of nangibotide was tested versus placebo.
Stage 1 was performed to investigate ascending doses of nangibotide or placebo in a sequential design in cohorts of 4 patients (3:1 randomisation). After completion of a cohort (for up to 5 days of infusion), safety and available PK data were blindly reviewed by an independent data safety monitoring board (DSMB) before progressing to the next cohort. After completion of stage 1 DSMB evaluation, the study progressed to stage 2.
Stage 2 investigated 3 doses of nangibotide in a randomised, balanced, parallel-group design involving up to 3 doses of nangibotide and a placebo arm. Only dose arms of nangibotide considered to be safe and well tolerated during Stage 1 were to be administered in Stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nangibotide 0.3 mg/kg/h | Experimental |
| |
| nangibotide 1.0 mg/kg/h | Experimental |
| |
| nangibotide 3.0 mg/kg/h | Experimental |
| |
| Placebo to nangibotide | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nangibotide 0.3 mg/kg | Drug | Formulated LR12 peptide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug. | Adverse events experienced until D28 (End of study visit) |
| Systolic Blood Pressure (SBP) | Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group. | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| Diastolic Blood Pressure (DBP) | Median DBP at each visit is summarized by treatment group. | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| Median Arterial Pressure (MAP) | MAP at each visit is summarized by treatment group. | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| Heart Rate | Median heart rate at each visit is summarized by treatment group. | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax | As no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg). |
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Inclusion Criteria:
Exclusion Criteria: -
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| Name | Affiliation | Role |
|---|---|---|
| Bruno François, MD | Inserm 1435 Clinical Investigational Center, Limoges, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc (there may be other sites in this country) | Brussels | Belgium | ||||
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The duration of this study for each patient was a maximum of 13 weeks (including screening, up to 5 days of treatment and follow-up assessments 28 and 90 days after randomization). The purpose of the screening phase was to confirm patient eligibility for enrolment in the study based on the inclusion and exclusion criteria and to obtain written ICF.
Patients were enrolled from 03 July 2017 (first patient first visit) to 11 June 2018 (last patient last visit) in 11 centers in 4 countries (Belgium, France, Spain, The Netherlands). 50 patients were included and randomized. 49 (98.0%) patients received the IMP and one patient died before IMP administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nangibotide 0.3 mg/kg/h | Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days. MOTREM: 0.3 mg/kg/h Formulated LR12 peptide |
| FG001 | Nangibotide 1.0 mg/kg/h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2019 |
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Randomised, Double-blind, Two-Stage, Placebo Controlled
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| Placebo | Drug | placebo |
|
| Nangibotide 1 mg/kg | Drug | Formulated LR12 peptide |
|
|
| Nangibotide 3 mg/kg | Drug | Formulated LR12 peptide |
|
|
| Temperature | Median temperature at each visit is summarized by treatment group. | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). |
| Electrocardiogram | Abnormal and emergent clinically significant electrocardiogram were summarized for each group. | Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS). |
| Anti-Drug Antibodies (ADA Dimer) | Anti-Drug Antibodies test was performed for all patients. | Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients. |
| Anti-Drug Antibodies (ADA Monomer) | Anti-Drug Antibodies test was performed for all patients. | Anti-Drug Antibodies test were measured at D0, D10 and D28. |
| Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
| Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax | Time to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups. | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
| Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method. | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
| Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg | Steady-state concentration during the maintenance infusion was calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study. | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
| Pharmacokinetic Parameters From the Non-compartmental Analysis: CL | Systemic clearance was calculated as the ratio between the infusion rate during the maintenance infusion and Cavg. | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
| Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country) |
| Limoges |
| France |
| Radboudumc (there may be other sites in this country) | Nijmegen | Netherlands |
| Hospital ClÃnico San Carlos, Medicina Intensiva (there may be other sites in this country) | Madrid | Spain |
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 1.0 mg/kg/h for up to 5 days. MOTREM: 1 mg/kg/hr Formulated LR12 peptide |
| FG002 | Nangibotide 3.0 mg/kg/h | Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 3.0 mg/kg/h for up to 5 days. MOTREM: 3 mg/kg/h Formulated LR12 peptide |
| FG003 | Placebo | Placebo: placebo The matching placebo (solution of NaCl 0.9%) was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nangibotide 0.3 mg/kg/h | Nangibotide: 0.3 mg/kg Formulated LR12 peptide |
| BG001 | Nangibotide 1.0 mg/kg/h | Nangibotide: 1 mg/kg Formulated LR12 peptide |
| BG002 | Nangibotide 3.0 mg/kg/h | Nangibotide: 3 mg/kg Formulated LR12 peptide |
| BG003 | Placebo | Placebo: placebo |
| BG004 | 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/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Full Range | kg |
| |||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||
| BMI | Median | Full Range | kg/m^2 |
|
| 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 | Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug. | Out of 49 patients included in all 4 groups, TEAEs were observed for 45 patients (12 patients experienced TEAEs in MOTREM 1 group, 12 patients experienced TEAEs in MOTREM 2 group, 11 patients experienced TEAEs in MOTREM 3 group and 10 patients experienced TEAEs in placebo group) | Posted | Count of Participants | Participants | Adverse events experienced until D28 (End of study visit) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Systolic Blood Pressure (SBP) | Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group. | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | Posted | Median | Full Range | mmHg | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| ||||||||||||||||||||||||||||||||||||
| Primary | Diastolic Blood Pressure (DBP) | Median DBP at each visit is summarized by treatment group. | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | Posted | Median | Full Range | mmHg | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| ||||||||||||||||||||||||||||||||||||
| Primary | Median Arterial Pressure (MAP) | MAP at each visit is summarized by treatment group. | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | Posted | Median | Full Range | mmHg | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). |
| ||||||||||||||||||||||||||||||||||||
| Primary | Heart Rate | Median heart rate at each visit is summarized by treatment group. | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. systolic blood pressure (mmHg). Diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate (bpm) and temperature i celcius degrees were described at each time when it was available: D0, D1, D2, D3, D4 and D5/EOI visit. | Posted | Median | Full Range | bpm | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). |
| ||||||||||||||||||||||||||||||||||||
| Primary | Temperature | Median temperature at each visit is summarized by treatment group. | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D0, D1, D2, D3, D4, D5/EOI visit. | Posted | Median | Full Range | °C | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). |
| ||||||||||||||||||||||||||||||||||||
| Primary | Electrocardiogram | Abnormal and emergent clinically significant electrocardiogram were summarized for each group. | Some patients did not perform ECG at some visits | Posted | Count of Participants | Participants | Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS). |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Anti-Drug Antibodies (ADA Dimer) | Anti-Drug Antibodies test was performed for all patients. | Posted | Count of Participants | Participants | Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients. |
|
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| Primary | Anti-Drug Antibodies (ADA Monomer) | Anti-Drug Antibodies test was performed for all patients. | The results are presented for the Day 28. | Posted | Count of Participants | Participants | Anti-Drug Antibodies test were measured at D0, D10 and D28. |
|
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| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax | As no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg). | Posted | Median | Full Range | ng/mL | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax | Time to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups. | Posted | Median | Full Range | h | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method. | Posted | Median | Full Range | ng*h/mL | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
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| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg | Steady-state concentration during the maintenance infusion was calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study. | Posted | Median | Full Range | ng/mL | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
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| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: CL | Systemic clearance was calculated as the ratio between the infusion rate during the maintenance infusion and Cavg. | Posted | Median | Full Range | L/h/kg | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI |
|
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From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: placebo | 3 | 12 | 7 | 12 | 10 | 12 |
| EG001 | Nangibotide 0.3 mg/kg/h | MOTREM: Formulated LR12 peptide | 4 | 13 | 4 | 13 | 12 | 13 |
| EG002 | Nangibotide 1.0 mg/kg/h | MOTREM: Formulated LR12 peptide | 2 | 12 | 2 | 12 | 12 | 12 |
| EG003 | Nangibotide 3.0 mg/kg/h | MOTREM: Formulated LR12 peptide | 4 | 12 | 4 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple organ failure syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemodynamic instability | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Mechanical ventilation complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Respiratory fatigue | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Confusional State | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Intra-Abdominal Fluid Collection | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Oral Fungal Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Septic Shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
None reported.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive VP Research and Medical Sciences | INOTREM SA | 30 62 86 51 | +33 (0)6 | jjg@inotrem.com |
| Jun 14, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C420324 | nangibotide |
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| Age>65 |
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| Male |
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| Black |
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| Other |
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Nangibotide: Formulated LR12 peptide
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| ECGs - Abnormal NCS |
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| ECGs - Missing |
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| Title | Measurements |
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| ECGs - Normal |
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| ECGs - Abnormal NCS |
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| ECGs - Abnormal CS |
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| ECGs - Missing |
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| Title | Measurements |
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| ECGs - Normal |
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| ECGs - Abnormal NCS |
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| ECGs - Abnormal CS |
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| ECGs - Missing |
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| Title | Measurements |
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| ECGs - Normal |
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| ECGs - Abnormal NCS |
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| ECGs - Abnormal CS |
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| ECGs - Missing |
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| Title | Measurements |
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| ECGs - Normal |
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| ECGs - Abnormal NCS |
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| ECGs - Abnormal CS |
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| ECGs - Missing |
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| Title | Measurements |
|---|---|
| ECGs - Normal |
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| ECGs - Abnormal NCS |
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| ECGs - Abnormal CS |
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| ECGs - Missing |
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| NEGATIVE |
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| POSITIVE |
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| NEGATIVE |
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| POSITIVE |
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| NEGATIVE |
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| POSITIVE |
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| NEGATIVE |
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| POSITIVE |
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