Study of Hetrombopag Safety and Effectiveness for Immune Thrombocytopenia Before Elective Surgery

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Hetrombopag in adults with immune thrombocytopenia who have low platelet counts before scheduled elective surgery. This prospective, single-arm clinical study aims to understand how well Hetrombopag can increase platelet levels in this specific patient group. The study is sponsored by The Third Peoples Hospital of Chengdu and is planned for up to 55 participants. Participants will receive oral Hetrombopag at a dose of 7.5 mg once daily at bedtime on an empty stomach for up to 14 days. Treatment will be stopped when platelet counts reach 100 x 109L and paused if counts rise to 200 x 109L or higher. Blood tests will be done weekly during treatment and more frequently if platelet counts drop to 30 x 109L or rise to 300 x 109L. The study includes a screening period of up to 7 days before treatment and a 30-day safety follow-up after stopping the drug. During the study, participants will have regular blood tests every 7 days or every 3 days depending on platelet levels to monitor their response and safety. An end-of-treatment visit will take place within 7 days after stopping medication. Researchers will measure platelet elevation over up to 14 days as the primary outcome. All participants will be monitored for safety during the follow-up period, which lasts 30 days after treatment ends.

Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia