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

Hengrui Medicine

Status and phase

Enrolling

Phase 3

Conditions

Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

Treatments

Drug: Herombopag placebo tablets

Drug: Herombopag tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT06507436

SHR8735-302

Details and patient eligibility

About

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.

Enrollment

101 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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