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Extension Study of Hetrombopag in Severe Aplastic Anemia
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.
Official title: Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia
Key Details
Gender
All
Age Range
15 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
157
Start Date
2019-09-19
Completion Date
2024-12-31
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Hetrombopag Olamine
Hetrombopag Olamine; once daily
Placebo
Placebo; once daily
Locations (1)
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China