Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 1:29 AM
Study NCT ID:
NCT05471050
Status:
UNKNOWN
Last Update Posted:
2022-07-22
First Post:
2022-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003613', 'term': 'Danazol'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2022-07-17', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained response', 'timeFrame': '6 months', 'description': 'Sustained response was defines as the maintenance of platelet count ≥ 30 x 10\\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication at the 6-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Complete response', 'timeFrame': '6 months', 'description': 'Complete response was defines as the maintenance of platelet count ≥ 100 x 10\\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.'}, {'measure': 'Response', 'timeFrame': '6 months', 'description': 'Response was defines as the maintenance of platelet count ≥ 30 x 10\\^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.'}, {'measure': 'Time to response', 'timeFrame': '6 months', 'description': 'Time to response was defined as the time from starting treatment to the time to achieve the response.'}, {'measure': 'Duration of response', 'timeFrame': '6 months', 'description': 'Duration of response was measured from the achievement of response to the loss of response.'}, {'measure': 'Adverse events', 'timeFrame': '6 months', 'description': 'Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune Thrombocytopenia', 'tacrolimus', 'danazol'], 'conditions': ['Immune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).', 'detailedDescription': 'The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary immune thrombocytopenia (ITP);\n* 18 years older;\n* Platelet count of less than 30×10\\^9/L at enrollment;\n* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;\n* Patients who were receiving other maintenance regimens, primarily corticosteroids, ciclosporin, or mycophenolate mofetil, were also eligible if the dose of treatment had been stable in the past month and the dose was expected to be stable after enrolment and remained unchanged at least for the first 4 weeks of study until initial response was assessed, unless severe adverse events were suspected.\n\nExclusion Criteria:\n\n* Secondary ITP (e.g., patients with HIV, HBV, HCV, Helicobacter pylori infection or SLE);\n* Congestive heart failure, severe arrhythmia;\n* Nursing or pregnant women;\n* ALT or AST levels ≥ 3× the upper limit of the normal threshold;\n* Creatinine or serum bilirubin levels ≥ 1.5× the upper limit;\n* Active or previous malignancy ;\n* Patients who had received danazol treatment or did not respond to danazol;\n* Patients unable to have routine blood tests because of reasons such as insufficient time.'}, 'identificationModule': {'nctId': 'NCT05471050', 'briefTitle': 'The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Open-label Trial', 'orgStudyIdInfo': {'id': 'PKU-ITP036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tacrolimus and Danazol', 'description': 'Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.', 'interventionNames': ['Drug: TAC', 'Drug: Danazol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Danazol', 'description': 'Danazol is given at 200mg bid for 12 weeks.', 'interventionNames': ['Drug: Danazol']}], 'interventions': [{'name': 'TAC', 'type': 'DRUG', 'description': 'Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.', 'armGroupLabels': ['tacrolimus and Danazol']}, {'name': 'Danazol', 'type': 'DRUG', 'description': 'Danazol is given at 200mg bid for 12 weeks.', 'armGroupLabels': ['Danazol', 'tacrolimus and Danazol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-hui Zhang, MD', 'role': 'CONTACT', 'email': 'zhangxh@bjmu.edu.cn', 'phone': '+8613522338836'}], 'facility': "Peking University Insititute of Hematology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'CONTACT', 'email': 'zhangxh@bjmu.edu.cn', 'phone': '+8613522338836'}, {'name': 'Xuan Cai, MD', 'role': 'CONTACT', 'email': '2206385254@qq.com', 'phone': '+8618811729606'}], 'overallOfficials': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital, Peking University Insititute of Hematology"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Peking Univeristy Institute of Hematology', 'investigatorFullName': 'Xiao Hui Zhang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}