Extension Study of Hetrombopag in Severe Aplastic Anemia

StatusUnknown
PhasePhase 3
Started

Record status This record was last updated September 19, 2024 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 180 to confirmed 157
    • Site details revised
    v2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.
Trial Details
NCT Number NCT04961710
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions
(from sponsor)		 Treatment-naive Severe Aplastic Anemia
Enrollment 157 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov