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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
157
Hetrombopag Olamine; once daily
Placebo; once daily
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The ratio of subjects with clonal evolution at 6 months and 18 months
Time frame: 6 months and 18 months
All SIEs, regardless of whether they are related to the investigational product
Time frame: 3 years
All SAEs, regardless of whether they are related to the investigational product
Time frame: 3 years
All AEs resulting in discontinuation and withdrawal from study
Time frame: 3 years
Red blood cell count
Time frame: by 1day visit
Hemoglobin
Time frame: by 1day visit
Platelet count
Time frame: by 1day visit
White blood cell count
Time frame: by 1day visit
Neutrophil count
Time frame: by 1day visit
Reticulocyte count
Time frame: by 1day visit
The 6-month and 18-month survival rates of subjects
Time frame: 6 months and 18 months
The recurrence rates at 6 months and 18 months
Time frame: 6 months and 18 months
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