Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT05678335
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2022-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tacrolimus for Thrombocytopenia in SS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2022-12-28', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunoglobulins', 'timeFrame': 'week 12', 'description': 'Change from baseline in Immunoglobulin (IgG, IgM and IgA) levels at week 12.'}, {'measure': 'Rheumatoid Factor', 'timeFrame': 'week 12', 'description': 'Change from baseline in rheumatoid factor level at week 12.'}], 'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': 'week 12', 'description': 'Complete response (platelet counts \\> 100×10\\^9/L) rates at week 12.'}], 'secondaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': 'week 4 and week 8', 'description': 'Complete response (platelet counts \\> 100×10\\^9/L) rates at week 4 and week 8.'}, {'measure': 'ESSDAI improvement', 'timeFrame': 'week 12', 'description': "Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at week 12."}, {'measure': 'ESSPRI improvement', 'timeFrame': 'week 12', 'description': "Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at week 12."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Sjogren's syndrome", 'Thrombocytopenia', 'Tacrolimus'], 'conditions': ['Sjogren Syndrome With Other Organ Involvement']}, 'descriptionModule': {'briefSummary': "This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.", 'detailedDescription': "This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.\n* Baseline platelet counts within 30-80×109/L.\n\nExclusion Criteria:\n\n* Concomitant other systemic autoimmune diseases.\n* Severe complications of Sjogren's syndrome.\n* Abnormal laboratory tests such as: white blood cell count \\<2.5x10\\^9/L, hemoglobin \\<80 g/L, AST/ALT \\>1.5 ULN, serum creatine \\> 1.5 mg/dL.\n* Received glucocorticoids, immunosuppressants, or biological agents within 3 months.\n* Active acute or chronic infections.\n* History of malignancy.\n* Pregnancy or breastfeeding."}, 'identificationModule': {'nctId': 'NCT05678335', 'briefTitle': 'Tacrolimus for Thrombocytopenia in SS', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': "Tacrolimus for Mild Thrombocytopenia in Sjogren's Syndrome", 'orgStudyIdInfo': {'id': 'I-22PJ1065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Hydroxychloroquine monotherapy', 'description': 'Oral hydroxychloroquine 200mg twice daily for 12 weeks.', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Tacrolimus monotherapy', 'description': 'Oral tacrolimus 1-2mg twice daily for 12 weeks.', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Oral hydroxychloroquine 200mg twice daily for 12weeks.', 'armGroupLabels': ['Hydroxychloroquine monotherapy']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Oral Tacrolimus 1-2mg twice daily for 12 weeks.', 'armGroupLabels': ['Tacrolimus monotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hua Chen, Dr.', 'role': 'CONTACT', 'email': 'chenhua@pumch.cn', 'phone': '861069159962'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Wen Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}