Status:
RECRUITING
The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, randomiz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06507436
Start Date
July 31 2024
End Date
December 1 2025
Last Update
November 18 2025
Active Locations (1)
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1
Zhongshan Hospital, affiliated with Fudan University
Shanghai, Shanghai Municipality, China, 200032