Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-07 @ 1:18 AM
Study NCT ID:
NCT03185793
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720748', 'term': 'ruzinurad'}, {'id': 'D001553', 'term': 'Benzbromarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-12', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with a serum uric level≤360μmol/l.', 'timeFrame': 'Week 5'}], 'secondaryOutcomes': [{'measure': 'Actual change from baseline in serum uric level.', 'timeFrame': 'Week 5'}, {'measure': 'Percentage change from baseline in serum uric level .', 'timeFrame': 'Week 5'}, {'measure': 'Rate of gout flares requiring treatment.', 'timeFrame': 'Up to week 5'}, {'measure': 'Incidence of gout flares requiring treatment.', 'timeFrame': 'Up to week 5'}, {'measure': 'Proportion of subjects with a serum uric level≤360μmol/l', 'timeFrame': 'At week1, 2, 3 and 4'}, {'measure': 'Proportion of subjects with a serum uric level consistent ≤360μmol/l', 'timeFrame': 'At week 3, 4 and 5'}, {'measure': 'Actual change from baseline in serum uric level', 'timeFrame': 'At week 1, 2, 3 and 4'}, {'measure': 'Percentage change from baseline in serum uric level', 'timeFrame': 'At week 1, 2, 3 and 4'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SHR4640, Phase II, monotherapy, dose-finding'], 'conditions': ['Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '33693494', 'type': 'DERIVED', 'citation': 'Lin Y, Chen X, Ding H, Ye P, Gu J, Wang X, Jiang Z, Li D, Wang Z, Long W, Li Z, Jiang G, Li X, Bi L, Jiang L, Wu J, Guo L, Cai X, Lu X, Chen Q, Chen H, Peng A, Zuo X, Ning R, Zhang Z, Tai Y, Zhang T, Bao C. Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study. Rheumatology (Oxford). 2021 Nov 3;60(11):5089-5097. doi: 10.1093/rheumatology/keab198.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-70 years, male or female;\n2. Subject meets one of the following conditions:\n\n1\\) Subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ BMI ≤32kg/m2.\n\nExclusion Criteria:\n\n1. Subject who is pregnant or breastfeeding;\n2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\\>1.5 upper normal limit;\n3. Estimated glomerular filtration rate (MDRD formula) ˂60ml/min;\n4. HbA1c˃8%;\n5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;\n6. Subject with a history of malignancy;\n7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen\n8. Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;\n9. Subject has acute gout flares within 2 weeks before randomization;\n10. Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;\n11. Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;\n12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study."}, 'identificationModule': {'nctId': 'NCT03185793', 'briefTitle': 'Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)', 'orgStudyIdInfo': {'id': 'SHR4640-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo for 5 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2.5mg SHR4640', 'description': 'SHR4640 for 5 weeks', 'interventionNames': ['Drug: SHR4640']}, {'type': 'EXPERIMENTAL', 'label': '5mg SHR4640', 'description': 'SHR4640 for 5 weeks', 'interventionNames': ['Drug: SHR4640']}, {'type': 'EXPERIMENTAL', 'label': '10mg SHR4640', 'description': 'SHR4640 for 5 weeks', 'interventionNames': ['Drug: SHR4640']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50mg benzbromarone', 'description': 'Benzbromarone for 5 weeks', 'interventionNames': ['Drug: benzbromarone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for 5 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'SHR4640', 'type': 'DRUG', 'description': '1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks', 'armGroupLabels': ['10mg SHR4640', '2.5mg SHR4640', '5mg SHR4640']}, {'name': 'benzbromarone', 'type': 'DRUG', 'description': '25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks', 'armGroupLabels': ['50mg benzbromarone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Jiangsu Hengrui Medicine Co., Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chunde Bao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}