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

Phase 3RecruitingNCT06507436

Jiangsu HengRui Medicine Co., Ltd.101 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

101

Conditions

Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.