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NCT Number: NCT04961710

Extension Study of Hetrombopag in Severe Aplastic Anemia

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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Treatment-naive Severe Aplastic Anemia

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
  • Subjects who have signed the informed consent form
  • 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
  • Subjects who have completed the end-of-treatment evaluation in the original study

Exclusion criteria

  • Any unstable situation or situation that will compromise the safety of the subject
  • Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
  • Subjects with uncontrollable hemorrhage and/or infection after standard treatment
  • Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
  • Any situation that may compromise the subject and the safety or compliance thereof during the study

Treatment and study plan

Hetrombopag Olamine

Drug

Hetrombopag Olamine; once daily

Placebo

Drug

Placebo; once daily

Primary outcomes

  1. The ratio of subjects with clonal evolution at 6 months and 18 months

    Time frame: 6 months and 18 months

  2. All SIEs, regardless of whether they are related to the investigational product

    Time frame: 3 years

  3. All SAEs, regardless of whether they are related to the investigational product

    Time frame: 3 years

  4. All AEs resulting in discontinuation and withdrawal from study

    Time frame: 3 years

Secondary outcomes

  1. Red blood cell count

    Time frame: by 1day visit

  2. Hemoglobin

    Time frame: by 1day visit

  3. Platelet count

    Time frame: by 1day visit

  4. White blood cell count

    Time frame: by 1day visit

  5. Neutrophil count

    Time frame: by 1day visit

  6. Reticulocyte count

    Time frame: by 1day visit

  7. The 6-month and 18-month survival rates of subjects

    Time frame: 6 months and 18 months

  8. The recurrence rates at 6 months and 18 months

    Time frame: 6 months and 18 months

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.