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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Zhongshan Hospital, affiliated with Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Ting Zhang
ting.zhang.tz89@hengrui.com
+86 0518-82342973
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 101
Treatments
Experimental: Treatment group 1
Experimental: Treatment group 2
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.