Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-01 @ 1:37 PM
Study NCT ID:
NCT07065968
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
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': 'C527525', 'term': 'teriflunomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained response', 'timeFrame': 'Week 24', 'description': 'Sustained response was defined as a platelet count ≥ 30 x10\\^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Initial response', 'timeFrame': 'Week 4', 'description': 'The number of participants with achievement of CR or R at 4 weeks. Complete response (CR) was defined as a platelet count ≥ 100 x10\\^9/L and absence of bleeding. Response (R) was defined as a platelet count ≥ 30 x10\\^9/L and at least a 2-fold increase of the baseline count and absence of bleeding. No response was defined as a platelet count of less than 30 x10\\^9/L, or less than two times increase from baseline platelet count, or bleeding.'}, {'measure': 'Time to response', 'timeFrame': 'Week 24', 'description': 'The time from treatment initiation to time of achievement of CR or R.'}, {'measure': 'Duration of response', 'timeFrame': 'Week 24', 'description': 'The time from the achievement of a CR or R to the loss of CR or R.'}, {'measure': 'Bleeding events', 'timeFrame': 'Week 24', 'description': 'Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.'}, {'measure': 'Adverse events', 'timeFrame': 'Week 24', 'description': 'Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': 'Week 24', 'description': 'ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Thrombocytopenia (ITP)']}, 'descriptionModule': {'briefSummary': 'A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).', 'detailedDescription': 'The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone 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'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥18 years;\n2. Newly diagnosed, treatment naïve ITP patients;\n3. Patients with a platelet count \\<30 x10\\^9/L or a platelet count \\<50 x10\\^9/L with bleeding manifestations at the enrollment;\n4. Willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n1. Secondary ITP such as drug-related thrombocytopenia, viral infection (HIV, hepatitis B virus, or hepatitis C virus);\n2. Pre-existing acute or chronic liver disease, or ALT/AST greater than 2 times the upper limit of normal (ULN);\n3. Severe cardiac, renal, hepatic, or respiratory insufficiency;\n4. Severe immunodeficiency;\n5. Pregnancy or lactation;\n6. Active or a history of malignancy;\n7. Active infection requiring systemic therapy;\n8. Myelodysplastic syndrome, aplastic anemia, or myelofibrosis;\n9. A known diagnosis of other autoimmune diseases;\n10. Patients who are deemed unsuitable for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT07065968', 'briefTitle': 'The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Teriflunomide and High-dose Dexamethasone vs High-dose Dexamethasone Alone as First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial', 'orgStudyIdInfo': {'id': 'TY2025006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teriflunomide plus Dexamethasone', 'description': 'Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10\\^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Teriflunomide', 'type': 'DRUG', 'description': 'Teriflunomide 14 mg orally once daily for 24 weeks.', 'armGroupLabels': ['Teriflunomide plus Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 40 mg orally once daily for four consecutive days.', 'armGroupLabels': ['Dexamethasone', 'Teriflunomide plus Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu-Jun Dong, MD', 'role': 'CONTACT', 'email': 'dongy@hsc.pku.edu.cn', 'phone': '+8618210264969'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'CONTACT', 'email': 'zhangxh@bjmu.edu.cn', 'phone': '+8613522338836'}, {'name': 'Li-Ping Yang, MD', 'role': 'CONTACT', 'email': 'lpyang@bjmu.edu.cn', 'phone': '+8618519172033'}], 'facility': "Peking University Insititute of Hematology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong-Mei Jing, MD', 'role': 'CONTACT', 'email': 'hongmeijing@bjmu.edu.cn', 'phone': '+8615611908428'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'CONTACT', 'email': 'zhangxh@bjmu.edu.cn', 'phone': '+8613522338836'}, {'name': 'Li-Ping Yang, MD', 'role': 'CONTACT', 'email': 'lpyang@bjmu.edu.cn', 'phone': '+8618519172033'}], 'overallOfficials': [{'name': 'Xiao-Hui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University Institute of Hematology, Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Health Science Center', 'class': 'OTHER'}, {'name': 'Cisen Pharmaceutical CO., LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Peking Univeristy Institute of Hematology', 'investigatorFullName': 'Xiao Hui Zhang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}