Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05438069
Status:
UNKNOWN
Last Update Posted:
2022-07-07
First Post:
2022-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C change', 'timeFrame': '3 months, 6 months, 12 months, 24 months', 'description': 'LDL-C change in mg/dL / mmol/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany', 'detailedDescription': 'The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '-patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran\n* patients 18 years and older\n\nExclusion Criteria:\n\n\\- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.'}, 'identificationModule': {'nctId': 'NCT05438069', 'acronym': 'GIN', 'briefTitle': 'German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany', 'orgStudyIdInfo': {'id': '2021-2429'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with elevated LDL-cholesterol (hypercholesterolemia)', 'description': 'Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver Weingärtner, MD', 'role': 'CONTACT', 'email': 'oliver.weingaertner@med.uni-jena.de', 'phone': '+4936419324521'}, {'name': 'Martin Foerster, PhD', 'role': 'CONTACT', 'email': 'Martin.Foerster@med.uni-jena.de', 'phone': '+4936419325818'}, {'name': 'Umidakhon Makhmudova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'centralContacts': [{'name': 'Oliver Weingaertner, MD', 'role': 'CONTACT', 'email': 'oliver.weingaertner@med.uni-jena.de', 'phone': '+4936419324521'}, {'name': 'Martin Foerster, PhD', 'role': 'CONTACT', 'email': 'martin.foerster@med.uni-jena.de', 'phone': '+4936419325818'}], 'overallOfficials': [{'name': 'Oliver Weingaertner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jena University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '3 months after publication for 3 years', 'ipdSharing': 'YES', 'description': 'Data that will be shared:\n\nStudy protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.', 'accessCriteria': 'Data that will be shared:\n\nStudy protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitätsklinikum Leipzig', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, {'name': 'University of Rostock', 'class': 'OTHER'}, {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, {'name': 'LMU Klinikum', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Oliver Weingärtner', 'investigatorAffiliation': 'Jena University Hospital'}}}}