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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
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This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.
The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication.
SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP16 | Experimental | Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP16 | Drug | All patients will receive a single dose of SP16 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) for C-reactive Protein (CRP) | This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP. | Baseline, 72 hours, 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB) | This study will estimate the infarct size based upon area under the curve (AUC) for creatine-kinase myocardial band (CK-MB). The AUC calculation will come from CK-MB levels drawn during usual care. The infarct size will then be compared to historical controls to evaluate whether or not SP16 reduces the infarct size. | 72 hours |
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In order to be eligible for this study, patients must meet all the 3 criteria:
In order to be eligible for this study, patients must meet none of the Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Abbate, MD, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35881895 | Derived | Van Tassell BW, Wohlford GF, Del Buono MG, Damonte JI, Markley R, Turlington J, Kadariya D, Talasaz A, Ho J, Marawan A, Thomas GK, Austin D, Gineste C, Gelber C, Abbate A. Safety, Tolerability, and Effects of a Single Subcutaneous Administration of SP16 - a SERPIN-like, Small Peptide Agonist of the Low-Density Lipoprotein-like Receptor 1- on the Acute Inflammatory Response in Patients With ST-Segment Elevation Myocardial Infarction. J Cardiovasc Pharmacol. 2022 Nov 1;80(5):672-678. doi: 10.1097/FJC.0000000000001331. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SP16 | Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SP16 | Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Area Under the Curve (AUC) for C-reactive Protein (CRP) | This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP. | Posted | Median | Inter-Quartile Range | mg*day/L | Baseline, 72 hours, 14 days |
|
|
12 months
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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 | SP16 | Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cohava Gelber | Serpin Pharma, LLC | 7033433258 | cgelber@serpinpharma.com |
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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 | Aug 21, 2020 | Dec 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days | Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF. | 365 days |
| Diagnosis of Heart Failure | Number of participants diagnosed with heart failure at 1 year follow up | 365 days |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB) | This study will estimate the infarct size based upon area under the curve (AUC) for creatine-kinase myocardial band (CK-MB). The AUC calculation will come from CK-MB levels drawn during usual care. The infarct size will then be compared to historical controls to evaluate whether or not SP16 reduces the infarct size. | Posted | Median | Inter-Quartile Range | ng/mL*day | 72 hours |
|
|
|
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days | Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF. | Posted | Median | Inter-Quartile Range | percentage of LVEF | 365 days |
|
|
|
| Secondary | Diagnosis of Heart Failure | Number of participants diagnosed with heart failure at 1 year follow up | Posted | Count of Participants | Participants | 365 days |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
PI shall be free to publish and/or present about the Study. All publications must be submitted to the sponsor at least 30 days prior to submission for review/comment. PI will consider any such comments in good faith but is under no obligation to incorporate. If Sponsor notifies PI that it desires patent applications, PI will defer Publication for a period not to exceed 60 days; & if Publication contains Company's Confidential, the PI agrees to delete such Company's Confidential Information.
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |