Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-01 @ 9:45 AM
Study NCT ID:
NCT04089267
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in Platelet count from baseline on day 14 after the first dose', 'timeFrame': 'for day 14'}, {'measure': 'Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.', 'timeFrame': 'for day 14'}], 'secondaryOutcomes': [{'measure': 'The change in Platelet count from baseline on day 7 and day28 after the first dose', 'timeFrame': 'for day7and day28'}, {'measure': 'the total effective rate of treatment in ITP patients on day 7 and day 28', 'timeFrame': 'for day7and day28'}, {'measure': 'AE', 'timeFrame': 'up to 28days'}, {'measure': 'Incidence of anti-rhTPO antibodies', 'timeFrame': 'up to 28days'}, {'measure': 'Cav', 'timeFrame': 'up to 28days', 'description': 'average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state'}, {'measure': 'AUCss', 'timeFrame': 'up to 28days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ITP']}, 'descriptionModule': {'briefSummary': 'This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).', 'detailedDescription': 'Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old, male or female\n* For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)\n* Recurrence after previous treatment with glucocorticoids is ineffective or effective\n* No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment\n* Platelet count before enrollment ≤ 30 × 109 / L, or \\> 30 × 109 / L but with active bleeding\n* Volunteer to participate in the study and sign the informed consent form\n\nExclusion Criteria:\n\n* pregnant or lactating\n* Those with a history of thrombosis\n* severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times\n* Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)\n* In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;\n* Severe or uncontrollable infections\n* have a history of mental illness\n* The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.'}, 'identificationModule': {'nctId': 'NCT04089267', 'briefTitle': 'Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenyang Sunshine Pharmaceutical Co., LTD.'}, 'officialTitle': 'Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)', 'orgStudyIdInfo': {'id': '3sbio-TPO-403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group 1', 'description': 'rhTPO injection7500 U ;one time a day; 14 times of administration', 'interventionNames': ['Drug: TPO']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group 2', 'description': 'rhTPO injection15000 U;one time a day;14 times of administration', 'interventionNames': ['Drug: TPO']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group 3', 'description': 'rhTPO injection15000 U;1 time every other day, 7 times;', 'interventionNames': ['Drug: TPO']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group 4', 'description': 'rhTPO injection30000 U；1 time every other day, 7 times;', 'interventionNames': ['Drug: TPO']}], 'interventions': [{'name': 'TPO', 'type': 'DRUG', 'armGroupLabels': ['experimental group 1', 'experimental group 2', 'experimental group 3', 'experimental group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510260', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510317', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Second People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '511400', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150010', 'city': 'Haerbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Institute of Hematology and Oncology'}, {'zip': '471003', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Henan University of Science and Technology First Affiliated Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Henan University of Traditional Chinese Medicine', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450007', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Zhengzhou Central Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'renmin Hospital of Wuhan University Hubei General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '417118', 'city': 'Loudi', 'state': 'Hunan', 'country': 'China', 'facility': 'Loudi Central Hospital', 'geoPoint': {'lat': 27.73444, 'lon': 111.99444}}, {'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '150040', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'First Affiliated Hospital Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '710499', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xi An Central Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences Blood Disease Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '323000', 'city': 'Lishui', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Lishui City Center Hospital', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}, {'city': 'Xinjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 30.46809, 'lon': 120.44325}}, {'zip': '453699', 'city': 'Xinxiang', 'country': 'China', 'facility': 'Xinxiang Central Hospital,', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Sunshine Pharmaceutical Co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}