Hetrombopag Olamine: Hetrombopag Olamine; once daily
Placebo: Placebo; once daily
Study 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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.
Eligibility
Sex
ALL
Min age
15 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
2. Subjects who have signed the informed consent form
3. Female and male subjects of childbearing age who agree to take adequate contraceptive measures during the extension study period and within 28 days after the last dose
4. Subjects who have completed the end-of-treatment evaluation in the original study
Exclusion Criteria:
1. Any unstable situation or situation that will compromise the safety of the subject
2. Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
3. Subjects with uncontrollable hemorrhage and/or infection after standard treatment
4. Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
5. Any situation that may compromise the subject and the safety or compliance thereof during the study
Primary outcome measure(s)
The ratio of subjects with clonal evolution at 6 months and 18 months — 6 months and 18 months
All SIEs, regardless of whether they are related to the investigational product — 3 years
All SAEs, regardless of whether they are related to the investigational product — 3 years
All AEs resulting in discontinuation and withdrawal from study — 3 years
Trial sites (1)
Facility
City
Region
Status
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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