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The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

Recruiting
18 years and older
All
Phase 3

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Overview

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

Eligibility

Inclusion Criteria:

  1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
  2. Platelet count less than 50×10^9/L on baseline;
  3. Elective invasive procedures or surgeries that are planned.

Exclusion Criteria:

  1. Any history of arterial or venous thrombosis, including partial or complete thrombosis;
  2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
  3. Portal vein blood flow velocity rate <10 centimeters/second at Screening;
  4. There are other diseases that may cause thrombocytopenia.

Study details
    Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

NCT06507436

Jiangsu HengRui Medicine Co., Ltd.

2 June 2025

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