An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
NCT ID: NCT05333861
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1150 participants
OBSERVATIONAL
2022-05-01
2026-05-01
Brief Summary
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Detailed Description
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Patients eligible for participation will, as part of their routine medical care, be receiving hetrombopag for the treatment of ITP/AA
The scope of the study is to collect both retrospective and prospective data. The main part of the study will be prospective collecting data on usage, effectiveness, safety and patient-reported outcomes whereas the retrospective part will consist of collection of information on previous treatments, reason for treatment switch and, if applicable, hetrombopag treatment prior to enrollment. The retrospective data collection will be based on the information available in the patient's medical records. Data will be collected for up to 12 months prior to hetrombopag treatment start.
Prospective data will be collected at routine clinical visits throughout the study. Patients will be followed for 24 months and will be enrolled until their first scheduled visit after 24 months of enrollment, or until early termination, whichever occurs first.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Full-analysis set (FAS)
The FAS includes all enrolled patients. The FAS will be used for all analyses.
hetrombopag
According to prescription
Interventions
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hetrombopag
According to prescription
Eligibility Criteria
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Inclusion Criteria
* 2.Patient is treated with, or at enrollment prescribed hetrombopag for ITP. Decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study.
* 3.Signed and dated informed consent provided by the patient before any study-related activities are undertaken
* 4.Willing and able to comply with protocol requirements
Exclusion Criteria
ALL
No
Sponsors
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Jiangsu Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Other Identifiers
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Hetrombopag-ITP/AA
Identifier Type: -
Identifier Source: org_study_id
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