Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT06568302
Status:
TERMINATED
Last Update Posted:
2025-02-10
First Post:
2024-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Armenia', 'Australia', 'Belgium', 'Canada', 'France', 'Germany', 'India', 'Italy', 'Poland', 'South Africa', 'Spain', 'Taiwan', 'Turkey (Türkiye)', 'United Kingdom', 'United States'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-19', 'mcpReleaseN': 4, 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-12-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011486', 'term': 'Protein C'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D019774', 'term': 'Blood Coagulation Factor Inhibitors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Study terminated due to business and strategic decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treated bleeds, expressed as annualized bleeding rate (ABR)', 'timeFrame': 'Month 0 to Month 25 or Early termination'}], 'secondaryOutcomes': [{'measure': 'Treated spontaneous bleeds (expressed as ABR)', 'timeFrame': 'Month 0 to Month 25 or Early termination'}, {'measure': 'Treated spontaneous joint bleeds (expressed as ABR)', 'timeFrame': 'Month 0 to Month 25 or Early termination'}, {'measure': 'All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available)', 'timeFrame': 'Month 0 to Month 25 or Early termination'}, {'measure': 'Total coagulation factor and/or bypass product consumption', 'timeFrame': 'Month 0 to Month 25 or Early termination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophilia', 'SerpinPC'], 'conditions': ['Hemophilia a', 'Hemophilia B', 'Hemophilia a with Inhibitor', 'Hemophilia B with Inhibitor']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants greater than or equal to (\\>=) 12 and less than or equal to (\\<=) 65 years of age at the time of informed consent\n* Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries.\n* Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation\n\nExclusion Criteria:\n\n* Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke\n* Participation in another interventional clinical trial, except for SerpinPC trials\n* Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study\n* Treatment with anticoagulant or antiplatelet drugs'}, 'identificationModule': {'nctId': 'NCT06568302', 'acronym': 'PRESent-6', 'briefTitle': 'The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'ApcinteX Ltd'}, 'officialTitle': 'A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial', 'orgStudyIdInfo': {'id': 'AP-0106'}, 'secondaryIdInfos': [{'id': '2023-509965-19', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SerpinPC', 'description': 'Participants will receive SerpinPC 1.2 milligrams/kilograms (mg/kg) subcutaneous injection every 2 weeks (Q2W) once they have completed treatment in a SerpinPC parent study.', 'interventionNames': ['Drug: SerpinPC']}], 'interventions': [{'name': 'SerpinPC', 'type': 'DRUG', 'otherNames': ['Activated Protein C (APC) inhibitor'], 'description': 'Administered as SC injection.', 'armGroupLabels': ['SerpinPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'ARENSIA Exploratory Medicine LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Institute of Oncology, ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ApcinteX Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centessa Pharmaceuticals plc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}