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

The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

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 Overview

• Status: Recruiting
• Conditions: Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
• Intervention / Treatment: Drug: Herombopag tablets; Drug: Herombopag placebo tablets

• Study Type: Interventional
• Enrollment (Estimated): 101
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ting Zhang; Phone Number: +86 0518-82342973; Email: ting.zhang.tz89@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital, affiliated with Fudan University
      • Contact: Jian Zhou, Doctor; Phone Number: +86-021-64041990; Email: zhou.jian@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1	Drug: Herombopag tablets; Herombopag tablets; dose 1 or dose 2, for 5 days; Drug: Herombopag placebo tablets; Herombopag placebo tablets; dose 1 or dose 2, for 5 days
Experimental: Treatment group 2	Drug: Herombopag tablets; Herombopag tablets; dose 1 or dose 2, for 5 days; Drug: Herombopag placebo tablets; Herombopag placebo tablets; dose 1 or dose 2, for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: CL/F		0 minute to 5 days
Part A: Vc/F		0 minute to 5 days
Part A: ka		0 minute to 5 days
Part A: Q/F		0 minute to 5 days
Part A: AUC0-tau		0 minute to 5 days
Part A: Cmax		0 minute to 5 days
Part A: Kin		0 minute to 35 days
Part A: Kout		0 minute to 35 days
Part A: Kdeg		0 minute to 35 days
Part A: Slope		0 minute to 35 days
The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery	Part B	0 minute to 11 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery	0 minute to 11 days
The duration of time during the study when the platelet count remains ≥50×10^9/L	0 minute to 35 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Digestive System Diseases; Hematologic Diseases; Blood Platelet Disorders; Liver Diseases; Thrombocytopenia
• Other Study ID Numbers: SHR8735-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No