NCT04961710

Extension Study of Hetrombopag in Severe Aplastic Anemia

Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.

Conditions

• Treatment-naive Severe Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Hetrombopag Olamine	Hetrombopag Olamine; once daily
DRUG	Placebo	Placebo; once daily

Timeline

• Start date: 2019-09-19
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2021-07-14
• Last updated: 2024-09-19

Locations

1 site across 1 country: China