Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-03 @ 2:27 PM
Study NCT ID:
NCT06504420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response(CR) rate at week 24', 'timeFrame': 'week 24', 'description': 'CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.'}, {'measure': 'Partial response (PR) rate at week 24', 'timeFrame': 'week 24', 'description': 'PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\\~25).'}], 'secondaryOutcomes': [{'measure': 'Complete response(CR) rate at week 48', 'timeFrame': 'week 48', 'description': 'CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）.'}, {'measure': 'Partial response (PR) rate at week 48', 'timeFrame': 'week 48', 'description': 'PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\\~25).'}, {'measure': 'Rate of Participants with adverse effects and serious adverse effects during treatment', 'timeFrame': 'baseline to week 48', 'description': 'Adverse effects include fever, rash, abnormal liver function, rate of new-onset infections and any abnormal measures after recivede study drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['APS'], 'conditions': ['Primary Antiphospholipid Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand and sign the informed consent form\n2. Male or Female\n3. aged 18-70 at the time of screening visit\n4. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS\n5. With the stable combination therapy\n\nExclusion Criteria:\n\n1. history of serious adverse events or contraindication to Sirolimus\n2. Catastrophic APS within 90 days\n3. Acute thrombosis within 30 days\n4. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases\n5. Historically positive HIV test or test positive at screening for HIV\n6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)\n7. Surgery treatment within one month\n8. History of malignant neoplasm within the last 5 years\n9. White blood cell counts\\<3×10\\*9/L\n10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value\n11. Pregnant or pregnancy preparation or breastfeed\n12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects'}, 'identificationModule': {'nctId': 'NCT06504420', 'briefTitle': 'The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients', 'orgStudyIdInfo': {'id': '20240125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirolimus', 'description': 'Sirolimus 1.5mg po. QD', 'interventionNames': ['Drug: Sirolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placeobo', 'description': 'Sirolimus placebo 1.5mg po. QD', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'description': 'Subjects will receive Sirolimus 1.5mg/d for 48 weeks in addition to their ongoing APS treatment regimen', 'armGroupLabels': ['Sirolimus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive Placebo 1.5mg/d for first 24 weeks and Sirolimus 1.5mg/d for next 24 weeks in addition to their ongoing APS treatment regimen', 'armGroupLabels': ['placeobo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liling Xu, Ph.D', 'role': 'CONTACT', 'email': 'xuliling1079@163.com', 'phone': '+86 010 88324173'}], 'overallOfficials': [{'name': 'Zhanguo Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking university peoples hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Rheumatology and immunology', 'investigatorFullName': 'Zhanguo Li', 'investigatorAffiliation': "Peking University People's Hospital"}}}}