Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 11:43 AM
Study NCT ID:
NCT04214951
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2019-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C520809', 'term': 'eltrombopag'}, {'id': 'D013926', 'term': 'Thrombopoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhangxh@bjmu.edu.cn', 'phone': '86-10-88324577', 'title': 'Dr. Xiaohui Zhang, Director of Clinical Trials', 'organization': "Peking University People's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated liver enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate at 6 Weeks After Switching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. 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The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'The percentage of patients who have reached platelet count ≥ 50×10\\^9/L at 6 weeks after switching.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatments Associated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Adverse event/serious adverse event associated with study drugs during 6 weeks after switching', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reasons of Switching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'title': 'lack of efficacy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'patient preference', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'side effects', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'platelet count fluctuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Reasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of participants with bleeding events of the two groups during 6 weeks after switching', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TOR (Time to Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The time to achieve platelet count ≥ 50×10\\^9/L after switching.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DOR (Duration of Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The duration of achieving platelet count ≥ 50×10\\^9/L after switching.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'FG001', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Human Thrombopoietin (Rh-TPO) Group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.\n\nRecombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.'}, {'id': 'BG001', 'title': 'Eltrombopag Group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.\n\nEltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '45'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '39'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-13', 'size': 1834269, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-08-13T10:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-17', 'studyFirstSubmitDate': '2019-12-28', 'resultsFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2019-12-28', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-17', 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate at 6 Weeks After Switching', 'timeFrame': '6 weeks', 'description': 'The percentage of patients who have reached platelet count ≥ 50×10\\^9/L at 6 weeks after switching.'}], 'secondaryOutcomes': [{'measure': 'Treatments Associated Adverse Events', 'timeFrame': '6 weeks', 'description': 'Adverse event/serious adverse event associated with study drugs during 6 weeks after switching'}, {'measure': 'Reasons of Switching', 'timeFrame': '6 weeks', 'description': 'Reasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation'}, {'measure': 'Number of Participants With Bleeding Events', 'timeFrame': '6 weeks', 'description': 'Number of participants with bleeding events of the two groups during 6 weeks after switching'}, {'measure': 'TOR (Time to Response)', 'timeFrame': '6 weeks', 'description': 'The time to achieve platelet count ≥ 50×10\\^9/L after switching.'}, {'measure': 'DOR (Duration of Response)', 'timeFrame': '6 weeks', 'description': 'The duration of achieving platelet count ≥ 50×10\\^9/L after switching.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune Thrombocytopenia', 'Recombinant human thrombopoietin', 'Eltrombopag', 'switching'], 'conditions': ['Corticosteroid-resistant or Relapsed ITP']}, 'referencesModule': {'references': [{'pmid': '21325604', 'type': 'BACKGROUND', 'citation': 'Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16.'}, {'pmid': '19846889', 'type': 'BACKGROUND', 'citation': 'Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.'}, {'pmid': '22740443', 'type': 'BACKGROUND', 'citation': 'Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood. 2012 Aug 2;120(5):960-9. doi: 10.1182/blood-2011-12-309153. Epub 2012 Jun 26.'}, {'pmid': '23594368', 'type': 'BACKGROUND', 'citation': 'Deutsch VR, Tomer A. Advances in megakaryocytopoiesis and thrombopoiesis: from bench to bedside. Br J Haematol. 2013 Jun;161(6):778-93. doi: 10.1111/bjh.12328. Epub 2013 Apr 18.'}, {'pmid': '23821332', 'type': 'BACKGROUND', 'citation': 'Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013 Jul;98(1):10-23. doi: 10.1007/s12185-013-1382-0. Epub 2013 Jul 3.'}, {'pmid': '24680422', 'type': 'BACKGROUND', 'citation': 'Bussel JB, Lakkaraja M. Thrombopoietic agents: there is still much to learn. Presse Med. 2014 Apr;43(4 Pt 2):e69-78. doi: 10.1016/j.lpm.2014.02.008. Epub 2014 Mar 27.'}, {'pmid': '24273485', 'type': 'BACKGROUND', 'citation': 'Wormann B. Clinical indications for thrombopoietin and thrombopoietin-receptor agonists. Transfus Med Hemother. 2013 Oct;40(5):319-25. doi: 10.1159/000355006. Epub 2013 Sep 11.'}, {'pmid': '22753022', 'type': 'BACKGROUND', 'citation': 'Wang S, Yang R, Zou P, Hou M, Wu D, Shen Z, Lu X, Li Y, Chen X, Niu T, Sun H, Yu L, Wang Z, Zhang Y, Chang N, Zhang G, Zhao Y. A multicenter randomized controlled trial of recombinant human thrombopoietin treatment in patients with primary immune thrombocytopenia. Int J Hematol. 2012 Aug;96(2):222-8. doi: 10.1007/s12185-012-1124-8. Epub 2012 Jun 30.'}, {'pmid': '19038790', 'type': 'BACKGROUND', 'citation': 'Erickson-Miller CL, Delorme E, Tian SS, Hopson CB, Landis AJ, Valoret EI, Sellers TS, Rosen J, Miller SG, Luengo JI, Duffy KJ, Jenkins JM. Preclinical activity of eltrombopag (SB-497115), an oral, nonpeptide thrombopoietin receptor agonist. Stem Cells. 2009 Feb;27(2):424-30. doi: 10.1634/stemcells.2008-0366.'}, {'pmid': '19631713', 'type': 'BACKGROUND', 'citation': 'Erhardt JA, Erickson-Miller CL, Aivado M, Abboud M, Pillarisetti K, Toomey JR. 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Alternate use of thrombopoietin receptor agonists in adult primary immune thrombocytopenia patients: A retrospective collaborative survey from Italian hematology centers. Am J Hematol. 2018 Jan;93(1):58-64. doi: 10.1002/ajh.24935. Epub 2017 Nov 9."}, {'pmid': '36535011', 'type': 'DERIVED', 'citation': 'Cai X, Fu H, Zhao X, Lu J, Jiang Q, Chang Y, Huang X, Zhang X. Switching between eltrombopag and recombinant human thrombopoietin in patients with immune thrombocytopenia: an observational study. Chin Med J (Engl). 2022 Oct 5;135(19):2344-2350. doi: 10.1097/CM9.0000000000002346.'}]}, 'descriptionModule': {'briefSummary': 'Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.', 'detailedDescription': 'Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10\\^9/L in the rh-TPO group and 300 × 10\\^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult ITP patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18 years or older\n\n2.Primary ITP\n\n3.Platelet count ≤ 30 × 109/l\n\n4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values\n\n5.Available follow-up of 2 months at least for each period\n\n6.Failed initial glucocorticosteroid treatment\n\n7.Unwillingness to accept splenectomy or failed splenectomy\n\n\\-\n\nExclusion Criteria:\n\n1. HIV, hepatitis B or C, Helicobacter pylori infection\n2. Malignancy\n3. Congenital or acquired immunologic deficit\n4. History of thrombosis plus two or more risk factors\n5. Nursing or pregnant women\n6. Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl\n7. Severe heart and lung dysfunctions -'}, 'identificationModule': {'nctId': 'NCT04214951', 'briefTitle': 'A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia', 'orgStudyIdInfo': {'id': 'ZXH-ITP2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recombinant human thrombopoietin (rh-TPO) group', 'description': 'Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\\^9/L. The efficacy, safety, and patient/physician preference will be assessed.', 'interventionNames': ['Drug: Recombinant human thrombopoietin (rh-TPO)']}, {'label': 'Eltrombopag group', 'description': 'Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\\^9/L.The efficacy, safety, and patient/physician preference will be assessed.', 'interventionNames': ['Drug: Eltrombopag']}], 'interventions': [{'name': 'Eltrombopag', 'type': 'DRUG', 'description': 'Patients will be given eltrombopag 50mg once daily for 6 weeks.', 'armGroupLabels': ['Eltrombopag group']}, {'name': 'Recombinant human thrombopoietin (rh-TPO)', 'type': 'DRUG', 'description': 'Patients will be given rh-TPO 300 U/kg once daily for 21 days.', 'armGroupLabels': ['Recombinant human thrombopoietin (rh-TPO) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Institute of Hematology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiao Hui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xiao Hui Zhang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}