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
Jiangsu HengRui Medicine Co., Ltd.
101 participants
Jul 31, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
Herombopag tablets; dose 1 or dose 2, for 5 days
Herombopag placebo tablets; dose 1 or dose 2, for 5 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06507436