protocolSection identificationModule nctId: NCT06287567, orgStudyIdInfo id: IIT2023078-EC-1, briefTitle: Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy, conditionsModule conditions: Idiopathic Thrombocytopenic Purpura, conditions: Immune Thrombocytopenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: Lusutrombopag Oral Tablet, outcomesModule primaryOutcomes measure: Percentage of Participants with a Platelet Response after 4 Weeks (Day 29), secondaryOutcomes measure: Percentage of Participants with a Platelet Response after 12 Weeks (Day 85), secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of ≥100x10^9/L in the Core Study, secondaryOutcomes measure: Change in Platelet Count, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment, secondaryOutcomes measure: Time to first Achieve a Platelet Count of ≥ 50x10^9/L, secondaryOutcomes measure: Time to first Achieve a Platelet Count of ≥100x10^9 /L, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively., secondaryOutcomes measure: Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate, secondaryOutcomes measure: Cumulated Number of Weeks of Response（≥50x10^9/L）, secondaryOutcomes measure: Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline, secondaryOutcomes measure: The Incidence and Rating of Bleeding Events During the Study, secondaryOutcomes measure: Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs), secondaryOutcomes measure: Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16, secondaryOutcomes measure: Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Hematology & Blood Diseases Hospital, city: Tianjin, state: Tianjin, zip: 300020, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False