Extension Study of Hetrombopag in Severe Aplastic Anemia

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Treatment-naive Severe Aplastic Anemia

Treatments: Drug: Hetrombopag Olamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04961710

HR-TPO-SAA-III-EXT

Details and patient eligibility

About

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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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

Enrollment: 157 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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 Subjects who have completed or withdrawn from the HR-TPO-SAA-III study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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 2 patient groups, including a placebo group

Hetrombopag Olamine

Experimental group

Treatment:

Drug: Hetrombopag Olamine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo