Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-20 @ 8:24 AM
Study NCT ID:
NCT06465303
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2024-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cardiac Troponin T (cTNT)', 'timeFrame': '24 hours', 'description': 'Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.'}, {'measure': 'Change in Creatinine kinase-MB (CK-MB)', 'timeFrame': '24 hours', 'description': 'Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.\n\nThe study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).', 'detailedDescription': 'An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with (STEMI).\n\nThe study population is men between 18-85 years and post-menopausal women up to 85 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting \\<12 hours and neutrophil to lymphocyte ratio (NLR) in the range of 3-17 at hospital admission (Please refer to inclusion criteria).\n\nThe participants will be given three 30-minute intravenous infusions of RTP-026 or placebo (the investigational product). The first dose is to be initiated within 2 hours following the establishment of reflow after PCI, and the following two study treatments with 8-hour intervals.\n\nThe purpose of this study is to evaluate the safety, tolerability and efficacy of RTP-026 versus placebo in multiple doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures\n* Men between 18-85 years of age and post-menopausal women up to 85 years of age\n* Acute onset of chest pain of \\< 12 hours duration\n* STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)\n* Eligible for primary PCI\n* NLR in the range of 7-17 at hospital admission. In patients with chest pain lasting \\> 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3.\n\nExclusion Criteria:\n\n* Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry\n* Previous exposure to RTP-026\n* Time from symptoms onset to primary PCI \\> 12 hours\n* Previous CABG\n* Evidence of active malignant disease\n* Ongoing treatment with immune suppressive compounds\n* Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures\n* Known contraindications to CMR\n* ORBI Risk Score \\> 12'}, 'identificationModule': {'nctId': 'NCT06465303', 'briefTitle': 'A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResoTher Pharma'}, 'officialTitle': 'An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)', 'orgStudyIdInfo': {'id': 'ResoTher-CS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RTP-026', 'interventionNames': ['Drug: RTP-026']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RTP-026', 'type': 'DRUG', 'description': 'Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;', 'armGroupLabels': ['RTP-026']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intervention is for each subject administered as three 30-minutes infusions of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Thomas Engstrøm, Prof. MD', 'role': 'CONTACT'}], 'facility': 'Hjertecenteret, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Irene Sandholdt', 'role': 'CONTACT', 'email': 'isa@croxxmed.com', 'phone': '+45 2015 7033'}, {'name': 'Samra J Sanni, PhD', 'role': 'CONTACT', 'email': 'sas@resotherpharma.com', 'phone': '+45 3120 8857'}], 'overallOfficials': [{'name': 'Thomas Engstrøm, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hjertecenteret, Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResoTher Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}