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| Name | Class |
|---|---|
| Cromos Pharma LLC | INDUSTRY |
| Data Management 365 | INDUSTRY |
| Keystat, LLC | INDUSTRY |
| R-Pharm |
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The goal of the study was to evaluate the effect of single administration of RPH-104 at 80 mg and 160 mg on parameters of systemic inflammation and outcomes of the disease in subjects with ST-segment elevation myocardial infarction (STEMI)
After signing the informed consent form, the investigator assessed the subject's eligibility for the study. The following procedures were performed during the screening: collection of medical history, recording previous and concomitant therapy, demographic data, recording 12-lead ECG findings on which STEMI diagnosis was based, recording date and time of STEMI symptom development, recording date, time and results of coronary angiography (CAG) at admission to the study site, measurement of blood neutrophil count, vital signs, physical examination including measurement of body weight (if hospital bed is available), blood sampling for hematology, biochemistry, determination of concentration of hsCRP and brain natriuretic peptide (BNP; N-terminal (NT)-pro hormone brain natriuretic peptide (NT-pro-BNP)), for females with retained reproductive potential - pregnancy test (test strips).
The subjects meeting selection criteria were randomized to one of the three groups (in 1:1:1 ratio) for single subcutaneous administration of RPH-104 80 mg, RPH-104 160 mg or placebo.
Screening, randomization and administration of the study products were made on the same (first) study day.
Further 4-week (28-day) clinical follow-up and additional 6- and 12-month clinical follow-up period were performed.
The end of clinical part of the study was the date of the last visit of the last subject within additional 12-month clinical follow-up.
The maximum number of screened patients was planned to be 146 subjects, 102 subjects were randomized, 34 subjects per group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPH-104 80 mg | Experimental | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites |
|
| RPH-104 160 mg | Experimental | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites |
|
| Placebo | Placebo Comparator | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPH-104 80 mg | Biological | solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Multiple Imputation Procedure) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 | Day 1 until Day 14 |
| High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (сomplete Cases) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 | Day 1 until Day 14 |
| High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Sensitivity Analysis, Multiple Imputation Procedure) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 (sensitivity analysis) | Day 1 until Day 14 |
| High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Sensitivity Analysis, Complete Cases) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 (sensitivity analysis) | Day 1 until Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| hsCRP AUC From Baseline Until Day 28 (Multiple Imputation Procedure) | hsCRP AUC from baseline (Day 1) until Day 28 | up to Day 28 |
| hsCRP AUC From Baseline Until Day 28 (Complete Cases) | hsCRP AUC from baseline (Day 1) until Day 28 |
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Inclusion Criteria:
Highly effective contraceptive methods include combination of two of the following methods (a+b or a+c or b+c):
oral, injection or implanted hormonal contraceptives; in case of oral contraceptives, the female subjects should administer the same product for at least 3 months prior to the study therapy;
intrauterine device or contraceptive system;
barrier methods: condom or occlusive cap (diaphragm or cervical cap / vaginal fornix cap) with spermicidal foam/gel/film/cream/vaginal suppository
Exclusion Criteria:
glucocorticoids at doses of > 1 mg/kg of methylprednisolone equivalent, tumor necrosis factor-alfa (TNFα) blockers, Interleukin-1 (IL-1) and other biological drugs, cyclosporine and other immunosuppressants. Non-steroidal anti-inflammatory drugs (NSAIDs) are allowed.
Immunization with live vaccines within 90 days prior to the study product administration.
Chronic systemic autoimmune or autoinflammatory diseases
Suspected necessity in cardiosurgery.
Oncology (or diagnosis of oncology within the last 5 years).
History of organ transplantation or necessity in transplantation at the screening initiation or scheduled transplantation during the study.
Neutropenia (absolute neutrophil count <1800/mm^3).
Participation in another clinical study within the previous 3 months prior to Screening visit.
Other medical (including mental) conditions or abnormal laboratory findings which may increase the risk for the subject associated with the study participation or administration of the study products or which may affect interpretation of the study results and, according to the investigator, render the subject ineligible for the study.*
*If, in the Investigator's opinion, administration of a non-live COVID-19 (SARS-CoV-2) vaccine increases the risk for the patient related to his/her participation in the study, the Investigator can make a decision not to include this patient into the study.
The subjects working at the study site or subjects working for Sponsor directly involved in this clinical study.
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| Name | Affiliation | Role |
|---|---|---|
| Yan Lavrovsky | R-Pharm Overseas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| University of Virginia Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39133774 | Derived | Abbate A, Van Tassell B, Bogin V, Markley R, Pevzner DV, Cremer PC, Meray I, Privalov DV, Taylor A, Grishin SA, Egorova AN, Ponomar EG, Lavrovsky Y, Samsonov MY; RPH-104 STEMI Study Investigators. Results of International, Double-Blind, Randomized, Placebo-Controlled, Phase IIa Study of Interleukin-1 Blockade With RPH-104 (Goflikicept) in Patients With ST-Segment-Elevation Myocardial Infarction (STEMI). Circulation. 2024 Aug 13;150(7):580-582. doi: 10.1161/CIRCULATIONAHA.124.069396. Epub 2024 Aug 12. No abstract available. | |
| 33902621 |
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Patients were enrolled at 11 sites (Russia - 8, USA - 3). A total of 102 patients were randomized. The safety set included all randomized patients.The full analysis set for efficacy analysis (FAS) included 101 patients (who received the study products and underwent at least one hsCRP measurement after administration of the study products. The Per Protocol Set (PPS) included 92 subjects from the FAS without significant protocol deviations affecting assessment of the primary efficacy parameter.
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| ID | Title | Description |
|---|---|---|
| FG000 | RPH-104 80 mg | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
| 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 | Oct 27, 2021 |
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| INDUSTRY |
| K-Research, LLC | INDUSTRY |
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|
| Placebo | Drug | Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
| up to Day 28 |
| Number of Patients With Fatal Outcomes (Cardiac and Non-cardiac) During 12-month Follow-up Period | Any fatal outcomes were evaluated by the investigators and Independent study outcome assessment committee (ISOAC). ISOAC assessments were considered as the main data for conclusions, the investigator's assessments were presented for informational purposes only. | up to Day 365 |
| Number of Patients With of Hospitalizations Due to Heart Failure (HF) or Other Cardiac Reasons Not Associated With HF, or Due to Non-cardiac Reasons During 12-month Follow-up Period | Number of patients with hospitalizations for any reason during 12-month follow-up period, assessed by ISOAC. | up to Day 365 |
| Number of Patients With New Cases of HF During 12-month Follow-up Period | New cases of HF are defined as hospitalization due to HF or an emergency outpatient visit due to heart failure. ISOAC assessment | up to Day 365 |
| Changes in Levels of Brain Natriuretic Peptide (BNP) During 12-month Follow-up Period Compared to Baseline | Change in levels of BNP during 12-month follow-up period compared to baseline. (Brain Natriuretic Peptide (BNP) was measured in pmol/L.) Increased levels of BNP can be considered as marker of hemodynamic stress and surrogate marker of Heart Failure. The reported Least square means and confidence interval were from a repeated measures model on log transformed BNP data containing treatment, visit as factors, log baseline BNP as a continuous covariate and treatment by visit as interaction terms. Due to log-transformed data, change from baseline was defined as division value at corresponding time point and baseline value, thus the smallest value of the change from baseline indicates a better outcome or improvement. | From Day 1 until Day 365 |
| Changes in End-diastolic (EDV) Volume After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: End-diastolic (EDV) volumes. Measured by echocardiography (Echo-CG) (in mL). The reported Least square means and confidence interval were from a repeated measures model on EDV data containing treatment, visit as factors, baseline EDV as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| BNP AUC From Day 1 (Baseline) Until Day 28 | up to Day 28 |
| NT-pro-BNP AUC From Day 1 (Baseline) Until Day 28 | up to Day 28 |
| Number of Patients With Fatal Outcomes (Due to Any Reason) or Hospitalizations Due to HF or Emergency Outpatient Visits Due to HF During 12-month Follow-up Period | ISOAC assessment | up to Day 365 |
| Number of Patients With Fatal Outcomes (Due to Any Reason) or Hospitalizations Due to HF During 12-month Follow-up Period | ISOAC assessment | up to Day 365 |
| Changes in Levels of Brain Natriuretic Peptide (NT-proBNP) During 12-month Follow-up Period Compared to Baseline | Change in levels of NT-proBNP during 12-month follow-up period compared to baseline. The reported Least square means and confidence interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit as factors, log transformed baseline NT-proBNP as a continuous covariate and treatment by visit as interaction terms. For log-transformed data change was defined as division value at corresponding time point and baseline value. | From Day 1 until Day 365 |
| Changes in End-systolic (ESV) Volume After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: End-systolic (ESV) volumes. Measured by echocardiography (Echo-CG) (in mL). The reported Least square means and confidence interval were from a repeated measures model on ESV data containing treatment, visit as factors, baseline ESV as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Ejection Fraction (EF) After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: Ejection fraction (EF) (Simpson method). Measured by echocardiography (Echo-CG) (in percentage). The reported Least square means and confidence interval were from a repeated measures model on EF data containing treatment, visit as factors, baseline EF as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Regional LV Function After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of regional LV function using the wall motion score index (WMSI), measured by Echo-CG. The wall motion score index was calculated by assigning each segment a score based on its systolic function (normal = 1 (the best), hypokinesis = 2, akinesis = 3, dyskinesis = 4 (the worst)). The WMSI is the sum of all segmental scores divided by the number of segments analyzed (scale 1 - 4). A wall motion score index of 1 is normal (the best outcome). The higher the wall motion score index the worse is the outcome. The reported Least square means and confidence interval were from a repeated measures model on Regional LV Function data containing treatment, visit as factors, baseline Regional LV Function data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Stroke Volume (SV) Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of Stroke Volume (SV), measured by Echo-CG. The reported Least square means and confidence interval were from a repeated measures model on SV data containing treatment, visit as factors, baseline SV data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Global Longitudinal Strain (GLS) Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of Global Longitudinal Strain (GLS), measured by Echo-CG. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. The reported Least square means and confidence interval were from a repeated measures model on GLS data containing treatment, visit as factors, baseline GLS data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes of Fractional Area Change (FAC) Compared to Baseline | Right atrium and ventricle assessment from the apical 4-chamber right ventricular-focused view (with maximal right ventricular basal dimension) in B-mode and M-mode: Fractional Area Change (FAC). The reported Least square means and confidence interval were from a repeated measures model on FAC data containing treatment, visit as factors, baseline FAC data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE) Parameter Compared to Baseline | Right atrium and ventricle assessment from the apical 4-chamber right ventricular-focused view (with maximal right ventricular basal dimension) in B-mode and M-mode: tricuspid annular plane systolic excursion (TAPSE). The reported Least square means and confidence interval were from a repeated measures model on TAPSE data containing treatment, visit as factors, baseline TAPSE data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Early Diastolic Transmitral Flow Velocity (E Velocity) Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Transmitral flow, pulsed wave (PW) Doppler, E. The reported Least square means and confidence interval were from a repeated measures model on E velocity data containing treatment, visit as factors, baseline E velocity data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Mitral Valve (MV) e'Sept Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Tissue Doppler Imaging, MV e'sept. Unit of measure is centimeter/second (cm/s). This is one of the diastolic function parameters (septal velocity fibrous ring of the mitral valve (MV)). The reported Least square means and confidence interval were from a repeated measures model on MV e'Sept data containing treatment, visit as factors, baseline MV e'Sept data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Mitral Valve e'Lat Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Tissue Doppler Imaging, MV e'lat. Unit of measure is centimeter/second (cm/s). This is one of the diastolic function parameters (lateral velocity of fibrous ring of the mitral valve (MV)). The reported Least square means and confidence interval were from a repeated measures model on MV e'Lat data containing treatment, visit as factors, baseline MV e'Lat data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in Left Ventricular Stroke Volume (LV SV) Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: LV outflow tract velocity-time integral (VTI) + Diameter. Tissue Doppler Imaging, LV Stroke Volume (pulse-wave Doppler mode). The reported Least square means and confidence interval were from a repeated measures model on LV SV data containing treatment, visit as factors, baseline LV SV data as a continuous covariate and treatment by visit as interaction terms. | From Day 1 Until Day 365 |
| Changes in hsCRP Levels During the Study Compared to Baseline | Change in levels of hsCRP during the study compared to baseline. The reported Least square means and confidence interval were from a repeated measures model on log transformed hsCRP data containing treatment, visit as factors, log transformed baseline hsCRP data as a continuous covariate and treatment by visit as interaction terms. For log-transformed data change was defined as division value at corresponding time point and baseline value. | From Day 1 until Day 28 |
| Charlottesville |
| Virginia |
| 22908 |
| United States |
| VCU Health-Virginia Commonwealth University Health | Richmond | Virginia | 23298-5051 | United States |
| State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after V.V. Vinogradov of Moscow Healthcare Department" | Moscow | 117292 | Russia |
| State Institution of Healthcare in Moscow "City Clinical Hospital № 51 Moscow Health Department" | Moscow | 121309 | Russia |
| Federal State Budgetary Institution "National Medical Research Center for Cardiology" of the Ministry of Healthcare of the Russian Federation | Moscow | 121552 | Russia |
| State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after V.V. Veresaev of Moscow Healthcare Department" | Moscow | 127644 | Russia |
| State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4" | Perm | 614107 | Russia |
| Ryazan State Medical University n.a. academician I.P. Pavlov on the basis of Regional Clinical cardiology Dispensary | Ryazan | 390026 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "Saint Martyr Elizabeth City Hospital" | Saint Petersburg | 197706 | Russia |
| The State Budgetary Health Care Institution of the Yaroslavl Region "Regional Clinical Hospital" | Yaroslavl | 150062 | Russia |
| Derived |
| Samsonov M, Bogin V, Van Tassell BW, Abbate A. Interleukin-1 blockade with RPH-104 in patients with acute ST-elevation myocardial infarction: study design and rationale. J Transl Med. 2021 Apr 26;19(1):169. doi: 10.1186/s12967-021-02828-z. |
| FG001 |
| RPH-104 160 mg |
subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial |
| FG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
| Safety Set |
|
| Full Analysis Set | One patient in the Placebo arm was excluded from FAS population due to absence of High-sensitivity C-reactive protein (hsCRP) baseline measurement (the central laboratory was notable to perform an assay due to hemolysis) |
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| Per Protocol Set |
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| Completed the Study Per Protocol |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RPH-104 80 mg | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
| BG001 | RPH-104 160 mg | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial |
| BG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
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| 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 | High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Multiple Imputation Procedure) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. Multiple imputation procedure was performed for hsCRP values which were missed on Day 14. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | Day 1 until Day 14 |
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| Primary | High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (сomplete Cases) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. The model included patients with complete data (complete cases) in the FAS population. No data imputations were performed. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | Day 1 until Day 14 |
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| Primary | High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Sensitivity Analysis, Multiple Imputation Procedure) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 (sensitivity analysis) | At the stage of final analysis, sensitivity analysis was performed for the per protocol population (PPS). Multiple imputation procedure was performed for hsCRP values which were missed on Day 14. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | Day 1 until Day 14 |
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| Primary | High-sensitive С-reactive Protein (hsCRP) Area Under Curve (AUC) From Baseline Until Day 14 (Sensitivity Analysis, Complete Cases) | hsCRP area under curve (AUC) from baseline (Day 1) until Day 14 (sensitivity analysis) | At the stage of final analysis, sensitivity analysis was performed for the per protocol population (PPS). The model included patients with complete data (complete cases) in the PPS population. No data imputations were performed. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | Day 1 until Day 14 |
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| Secondary | hsCRP AUC From Baseline Until Day 28 (Multiple Imputation Procedure) | hsCRP AUC from baseline (Day 1) until Day 28 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. Multiple imputation procedure was performed for hsCRP values which were missed on Day 28. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | up to Day 28 |
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| Secondary | hsCRP AUC From Baseline Until Day 28 (Complete Cases) | hsCRP AUC from baseline (Day 1) until Day 28 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. The model included patients with complete data (complete cases) in the FAS population. No data imputations were performed. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg*day/L | up to Day 28 |
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| Secondary | Number of Patients With Fatal Outcomes (Cardiac and Non-cardiac) During 12-month Follow-up Period | Any fatal outcomes were evaluated by the investigators and Independent study outcome assessment committee (ISOAC). ISOAC assessments were considered as the main data for conclusions, the investigator's assessments were presented for informational purposes only. | Analysis was performed at the stage of final analysis for the FAS population. Data for fatal cases (deaths) were derived from CRF records. The CRF provided "Yes", "No" and "Unknown" for patient's alive status. Unknown was naturally missing data. | Posted | Count of Participants | Participants | up to Day 365 |
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| Secondary | Number of Patients With of Hospitalizations Due to Heart Failure (HF) or Other Cardiac Reasons Not Associated With HF, or Due to Non-cardiac Reasons During 12-month Follow-up Period | Number of patients with hospitalizations for any reason during 12-month follow-up period, assessed by ISOAC. | Analysis was performed at the stage of final analysis for the FAS population. | Posted | Count of Participants | Participants | up to Day 365 |
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| Secondary | Number of Patients With New Cases of HF During 12-month Follow-up Period | New cases of HF are defined as hospitalization due to HF or an emergency outpatient visit due to heart failure. ISOAC assessment | FAS population | Posted | Count of Participants | Participants | up to Day 365 |
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| Secondary | Changes in Levels of Brain Natriuretic Peptide (BNP) During 12-month Follow-up Period Compared to Baseline | Change in levels of BNP during 12-month follow-up period compared to baseline. (Brain Natriuretic Peptide (BNP) was measured in pmol/L.) Increased levels of BNP can be considered as marker of hemodynamic stress and surrogate marker of Heart Failure. The reported Least square means and confidence interval were from a repeated measures model on log transformed BNP data containing treatment, visit as factors, log baseline BNP as a continuous covariate and treatment by visit as interaction terms. Due to log-transformed data, change from baseline was defined as division value at corresponding time point and baseline value, thus the smallest value of the change from baseline indicates a better outcome or improvement. | Analysis was performed at the stage of final analysis for the FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ratio | From Day 1 until Day 365 |
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| Secondary | Changes in End-diastolic (EDV) Volume After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: End-diastolic (EDV) volumes. Measured by echocardiography (Echo-CG) (in mL). The reported Least square means and confidence interval were from a repeated measures model on EDV data containing treatment, visit as factors, baseline EDV as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | ml | From Day 1 Until Day 365 |
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| Secondary | BNP AUC From Day 1 (Baseline) Until Day 28 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. The model included patients with complete data (complete cases). | Posted | Geometric Least Squares Mean | 95% Confidence Interval | pmol*day/L | up to Day 28 |
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| Secondary | NT-pro-BNP AUC From Day 1 (Baseline) Until Day 28 | Full analysis set for efficacy analysis included all randomized subjects who received the study products (RPH-104 or placebo), and underwent at least one hsCRP measurement after administration of the study products. The FAS was the main population for efficacy assessment. The model included patients with complete data (complete cases). | Posted | Geometric Least Squares Mean | 95% Confidence Interval | pmol*day/L | up to Day 28 |
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| Secondary | Number of Patients With Fatal Outcomes (Due to Any Reason) or Hospitalizations Due to HF or Emergency Outpatient Visits Due to HF During 12-month Follow-up Period | ISOAC assessment | FAS population | Posted | Count of Participants | Participants | up to Day 365 |
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| Secondary | Number of Patients With Fatal Outcomes (Due to Any Reason) or Hospitalizations Due to HF During 12-month Follow-up Period | ISOAC assessment | FAS population | Posted | Count of Participants | Participants | up to Day 365 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Levels of Brain Natriuretic Peptide (NT-proBNP) During 12-month Follow-up Period Compared to Baseline | Change in levels of NT-proBNP during 12-month follow-up period compared to baseline. The reported Least square means and confidence interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit as factors, log transformed baseline NT-proBNP as a continuous covariate and treatment by visit as interaction terms. For log-transformed data change was defined as division value at corresponding time point and baseline value. | Analysis was performed at the stage of final analysis for the FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ratio | From Day 1 until Day 365 |
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| Secondary | Changes in End-systolic (ESV) Volume After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: End-systolic (ESV) volumes. Measured by echocardiography (Echo-CG) (in mL). The reported Least square means and confidence interval were from a repeated measures model on ESV data containing treatment, visit as factors, baseline ESV as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | ml | From Day 1 Until Day 365 |
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| Secondary | Changes in Ejection Fraction (EF) After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: Ejection fraction (EF) (Simpson method). Measured by echocardiography (Echo-CG) (in percentage). The reported Least square means and confidence interval were from a repeated measures model on EF data containing treatment, visit as factors, baseline EF as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of blood | From Day 1 Until Day 365 |
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| Secondary | Changes in Regional LV Function After 12 Months Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of regional LV function using the wall motion score index (WMSI), measured by Echo-CG. The wall motion score index was calculated by assigning each segment a score based on its systolic function (normal = 1 (the best), hypokinesis = 2, akinesis = 3, dyskinesis = 4 (the worst)). The WMSI is the sum of all segmental scores divided by the number of segments analyzed (scale 1 - 4). A wall motion score index of 1 is normal (the best outcome). The higher the wall motion score index the worse is the outcome. The reported Least square means and confidence interval were from a repeated measures model on Regional LV Function data containing treatment, visit as factors, baseline Regional LV Function data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | index units | From Day 1 Until Day 365 |
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| Secondary | Changes in Stroke Volume (SV) Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of Stroke Volume (SV), measured by Echo-CG. The reported Least square means and confidence interval were from a repeated measures model on SV data containing treatment, visit as factors, baseline SV data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | ml | From Day 1 Until Day 365 |
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| Secondary | Changes in Global Longitudinal Strain (GLS) Compared to Baseline | Apical 4-, 2-, and 3-chamber view in B-mode: assessment of Global Longitudinal Strain (GLS), measured by Echo-CG. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. The reported Least square means and confidence interval were from a repeated measures model on GLS data containing treatment, visit as factors, baseline GLS data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of myocardial shortening | From Day 1 Until Day 365 |
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| Secondary | Changes of Fractional Area Change (FAC) Compared to Baseline | Right atrium and ventricle assessment from the apical 4-chamber right ventricular-focused view (with maximal right ventricular basal dimension) in B-mode and M-mode: Fractional Area Change (FAC). The reported Least square means and confidence interval were from a repeated measures model on FAC data containing treatment, visit as factors, baseline FAC data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | From Day 1 Until Day 365 |
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| Secondary | Changes in Tricuspid Annular Plane Systolic Excursion (TAPSE) Parameter Compared to Baseline | Right atrium and ventricle assessment from the apical 4-chamber right ventricular-focused view (with maximal right ventricular basal dimension) in B-mode and M-mode: tricuspid annular plane systolic excursion (TAPSE). The reported Least square means and confidence interval were from a repeated measures model on TAPSE data containing treatment, visit as factors, baseline TAPSE data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | mm | From Day 1 Until Day 365 |
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| Secondary | Changes in Early Diastolic Transmitral Flow Velocity (E Velocity) Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Transmitral flow, pulsed wave (PW) Doppler, E. The reported Least square means and confidence interval were from a repeated measures model on E velocity data containing treatment, visit as factors, baseline E velocity data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | From Day 1 Until Day 365 |
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| Secondary | Changes in Mitral Valve (MV) e'Sept Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Tissue Doppler Imaging, MV e'sept. Unit of measure is centimeter/second (cm/s). This is one of the diastolic function parameters (septal velocity fibrous ring of the mitral valve (MV)). The reported Least square means and confidence interval were from a repeated measures model on MV e'Sept data containing treatment, visit as factors, baseline MV e'Sept data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | cm/s | From Day 1 Until Day 365 |
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| Secondary | Changes in Mitral Valve e'Lat Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: Tissue Doppler Imaging, MV e'lat. Unit of measure is centimeter/second (cm/s). This is one of the diastolic function parameters (lateral velocity of fibrous ring of the mitral valve (MV)). The reported Least square means and confidence interval were from a repeated measures model on MV e'Lat data containing treatment, visit as factors, baseline MV e'Lat data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | cm/s | From Day 1 Until Day 365 |
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| Secondary | Changes in Left Ventricular Stroke Volume (LV SV) Compared to Baseline | Assessment of diastolic and systolic function, apical 4-chamber view in pulse-wave Doppler mode, tissue Doppler mode: LV outflow tract velocity-time integral (VTI) + Diameter. Tissue Doppler Imaging, LV Stroke Volume (pulse-wave Doppler mode). The reported Least square means and confidence interval were from a repeated measures model on LV SV data containing treatment, visit as factors, baseline LV SV data as a continuous covariate and treatment by visit as interaction terms. | FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Least Squares Mean | 95% Confidence Interval | ml | From Day 1 Until Day 365 |
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| Secondary | Changes in hsCRP Levels During the Study Compared to Baseline | Change in levels of hsCRP during the study compared to baseline. The reported Least square means and confidence interval were from a repeated measures model on log transformed hsCRP data containing treatment, visit as factors, log transformed baseline hsCRP data as a continuous covariate and treatment by visit as interaction terms. For log-transformed data change was defined as division value at corresponding time point and baseline value. | Analysis was performed at the stage of final analysis for the FAS population. No data imputations were performed. Here, "Number Analyzed" indicates patients with assessable date each corresponding time point. Change from baseline was calculated for patients who had data at baseline and corresponding time point. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | ratio | From Day 1 until Day 28 |
|
Information on all Adverse Events (AEs) was collected since signing informed consent form (ICF) and until the study completion by the subject (up to day 365). SAEs for every participant were recorded since his/her signing ICF and for up to 30 days after the study product treatment discontinuation or until the last visit of the participant whichever is the latter, assessed up to 365 days. (AEs recorded prior to the study product administration were added to eCRF section "Medical history".)
Safety set included all randomized subjects, who received the study products (RPH-104 or placebo). This population was used for the safety analysis.
The tables below show:
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 | RPH-104 80 mg | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of placebo on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial | 1 | 34 | 7 | 34 | 21 | 34 |
| EG001 | RPH-104 160 mg | subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial | 0 | 34 | 1 | 34 | 20 | 34 |
| EG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial | 1 | 34 | 4 | 34 | 14 | 34 |
| EG003 | Pre-treatment Monitoring of "RPH-104 80 mg" Group | subjects randomized to group "RPH-104 80 mg" assessed between the date of the patient being enrolled in the study (by signing the ICF) and the time of application of randomized treatment (before receiving the target treatment) | 0 | 34 | 0 | 34 | 3 | 34 |
| EG004 | Pre-treatment Monitoring of "RPH-104 160 mg" Group | subjects randomized to group "RPH-104 160 mg" assessed between the date of the patient being enrolled in the study (by signing the ICF) and the time of application of randomized treatment (before receiving the target treatment) | 0 | 34 | 0 | 34 | 3 | 34 |
| EG005 | Pre-treatment Monitoring of Placebo Group | subjects randomized to placebo group assessed between the date of the patient being enrolled in the study (by signing the ICF) and the time of application of randomized treatment (before receiving the target treatment) | 0 | 34 | 0 | 34 | 2 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Brachiocephalic arteriosclerosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Any study related information could be made public available only after Sponsors written permission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Grishin, Director, Dep. of Clinical Development and Medical Expertise in Autoimmune Diseases | R-Pharm | 0074959567937 | 1506 | sa.grishin@rpharm.ru |
| Sep 15, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Hispanic |
|
| The following (two-sided) hypotheses were tested:
| Least square means ratio | 0.58 | 2-Sided | 95 | 0.37 | 0.91 | Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo. Ratio was calculated instead of difference because log data transformation. | Other |
| Placebo |
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
|
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial
|
|
|
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial
|
|
|
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites
Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial
|
|
|
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
|
| Placebo |
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
|
|
|
|
| OG001 |
| RPH-104 160 mg |
subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial |
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG001 |
| RPH-104 160 mg |
subjects received subcutaneous single injection of 2 mL (80 mg) of RPH-104 and 2 mL of (80 mg) of RPH-104 on different administration sites RPH-104 80 mg: solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial |
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 |
| Placebo |
subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|
| OG002 | Placebo | subjects received subcutaneous single injection of 2 mL of placebo and 2 mL of placebo on different administration sites Placebo: Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial |
|
|