Clinical Trial

Extension Study of Hetrombopag in Severe Aplastic Anemia

Active, Not Recruiting Phase 3
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Record status
This record was last updated September 19, 2024 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study. Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions. The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-07-13.
Status change: Recruiting → Active, Not Recruiting 2024-09-11
Trial Details
NCT Number NCT04961710
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Treatment-naive Severe Aplastic Anemia
Enrollment 157 participants
Start Date 2019-09-19
Primary Completion 2024-11-30 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-19