Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT04225533
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2020-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SP16 Inflammatory Response Inhibition Trial
Sponsor:
Organization:
Raw JSON
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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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) for C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '528'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 72 hours, 14 days', 'description': '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.', 'unitOfMeasure': 'mg*day/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'classes': [{'categories': [{'measurements': [{'value': '1432', 'groupId': 'OG000', 'lowerLimit': '675', 'upperLimit': '3089'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'description': '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.', 'unitOfMeasure': 'ng/mL*day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '365 days', 'description': 'Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF.', 'unitOfMeasure': 'percentage of LVEF', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diagnosis of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '365 days', 'description': 'Number of participants diagnosed with heart failure at 1 year follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection\n\nSP16: All patients will receive a single dose of SP16'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-21', 'size': 811491, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-08T16:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'dispFirstSubmitDate': '2022-01-07', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2020-01-08', 'dispFirstSubmitQcDate': '2023-01-04', 'resultsFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2020-01-08', 'dispFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-04', 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve (AUC) for C-reactive Protein (CRP)', 'timeFrame': 'Baseline, 72 hours, 14 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)', 'timeFrame': '72 hours', 'description': '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.'}, {'measure': 'Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days', 'timeFrame': '365 days', 'description': 'Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF.'}, {'measure': 'Diagnosis of Heart Failure', 'timeFrame': '365 days', 'description': 'Number of participants diagnosed with heart failure at 1 year follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '35881895', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSP16 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'In order to be eligible for this study, patients must meet all the 3 criteria:\n\n1. Presentation to the hospital with acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and electrocardiogram (ECG) evidence of ST segment elevation (\\>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);\n2. Coronary intervention planned and/or completed within 12 hours of symptom onset, and enrollment in the study within 6 hours of angiogram (max 18 hours from symptom onset)\n3. Age\\>21 years\n\nIn order to be eligible for this study, patients must meet none of the Exclusion criteria.\n\n* Inability to give informed consent\n* Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)\n* Pregnancy or breastfeeding\n* Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)\n* Preexisting severe left ventricular dysfunction (LVEF\\<20%)\n* Preexisting severe valvular heart disease\n* Known active infections (acute or chronic)\n* Recent (\\<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids \\[\\>1 mg/kg of prednisone equivalent\\], tumor necrosis factor-alpha blockers, cyclosporine) not including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used for intravenous (IV) dye allergy only)\n* Recent (\\<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)\n* Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)\n* Known active malignancy of any type, or prior diagnosis in the past 10 years\n* Neutropenia (absolute neutrophil count\\<1,800/mm3 \\[or \\<1,000/mm3 in African American patients\\])\n* Severe impairment in renal function (estimated glomerular filtration rate \\<30 ml/kg\\*min)\n* Anticipated need for cardiac or major surgery\n* Known Allergy to SP16'}, 'identificationModule': {'nctId': 'NCT04225533', 'acronym': 'SPIRIT', 'briefTitle': 'SP16 Inflammatory Response Inhibition Trial', 'organization': {'class': 'OTHER', 'fullName': 'Serpin Pharma, LLC'}, 'officialTitle': 'SP16 Inflammatory Response Inhibition Trial', 'orgStudyIdInfo': {'id': 'HM20018201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP16', 'description': 'Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection', 'interventionNames': ['Drug: SP16']}], 'interventions': [{'name': 'SP16', 'type': 'DRUG', 'description': 'All patients will receive a single dose of SP16', 'armGroupLabels': ['SP16']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Antonio Abbate, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serpin Pharma, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Virginia Commonwealth University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}