Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-18 @ 3:52 AM
Study NCT ID:
NCT06686927
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
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': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'C488777', 'term': 'romiplostim'}], 'ancestors': [{'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total effective rate of treatment for 30 days', 'timeFrame': 'one months', 'description': 'GR = CR + R (Complete reaction CR, platelet count ≥ 100×10\\^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10\\^9/L and 100×10\\^9/L, and at least double the baseline value, and no bleeding symptoms)'}], 'secondaryOutcomes': [{'measure': 'Early (week) response rate R', 'timeFrame': 'one months', 'description': 'Effective R, platelet count between 30×10\\^9/L and 100×10\\^9/L, and at least double the baseline value, and no bleeding symptoms'}, {'measure': 'Early Complete Response Rate (CR)', 'timeFrame': 'one months', 'description': 'Complete reaction CR, platelet count ≥ 100×10\\^9/L, and no bleeding symptoms'}, {'measure': 'Time to Reaction', 'timeFrame': 'one months', 'description': 'Time of Starting Treatment Until Platelet Count ≥ 30×10\\^9/L'}, {'measure': 'Adverse events during treatment', 'timeFrame': 'four months', 'description': 'evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events(NCI CTC AE)"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe ITP', 'Romiplostim'], 'conditions': ['Primary Immune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:\n\nTO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.\n\nParticipants will:\n\nRomiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.\n\nIVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.\n\nPrednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must sign a written informed consent prior to enrollment;\n2. Ages 18-75;\n3. Platelet count \\<10×10\\^9/L with active bleeding or bleeding score ≥5;\n4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;\n5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment;\n6. No prior romiplostim treatment;\n7. ECOG PS score: 0-2;\n8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;\n9. Voluntary participation in this study and good compliance.\n\nExclusion Criteria:\n\n1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;\n2. Individuals with a history of thrombosis;\n3. Pregnant or lactating individuals;\n4. Individuals with severe cardiopulmonary insufficiency;\n5. Individuals with severe or uncontrollable infections;\n6. Individuals with viral infections;\n7. Individuals who cannot comply due to psychological reasons;\n8. Individuals who are deemed unsuitable for participation in the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT06686927', 'briefTitle': 'Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP', 'orgStudyIdInfo': {'id': '2024-0503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corticosteroids combined with immunoglobulin and romiplostim', 'description': 'Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.\n\nIVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.\n\nPrednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.', 'interventionNames': ['Drug: corticosteroids combined with immunoglobulin and romiplostim']}], 'interventions': [{'name': 'corticosteroids combined with immunoglobulin and romiplostim', 'type': 'DRUG', 'description': 'Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.\n\nIVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.\n\nPrednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.', 'armGroupLabels': ['Corticosteroids combined with immunoglobulin and romiplostim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Hu, MD', 'role': 'CONTACT', 'email': 'dr_huyu387@163.com', 'phone': '027-85726114'}, {'name': 'Liang Tang', 'role': 'CONTACT', 'email': 'lancet.tang@qq.com', 'phone': '13554153411'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Liang Tang', 'role': 'CONTACT', 'email': 'lancet.tang@qq.com', 'phone': '13554153411'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}