Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-31 @ 2:39 PM
Study NCT ID:
NCT06009393
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}], 'ancestors': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in calculated LDL-C from baseline to week 12', 'timeFrame': 'from baseline to week 12'}], 'secondaryOutcomes': [{'measure': 'Change in calculated LDL-C from baseline to week 12', 'timeFrame': 'from baseline to week 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Homozygous Familial Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol\n2. LDL-C ≥2.6mmol/L at the screening visit\n3. Body weight ≥40 kg\n4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.\n\nExclusion Criteria:\n\n1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \\> 8.5%)\n2. eGFR \\<30ml/min/1.73m2 at the screening visit\n3. CK \\>5times ULN at the screening visit'}, 'identificationModule': {'nctId': 'NCT06009393', 'briefTitle': 'Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Suncadia Pharmaceuticals Co., Ltd'}, 'officialTitle': 'A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'SHR-1918-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1918', 'interventionNames': ['Drug: SHR-1918']}], 'interventions': [{'name': 'SHR-1918', 'type': 'DRUG', 'description': 'Three administration', 'armGroupLabels': ['SHR-1918']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410007', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Suncadia Pharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}