The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Phase 3
Recruiting
- Conditions
- Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
- Interventions
- Drug: Herombopag placebo tablets
- Registration Number
- NCT06507436
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 101
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group 1 Herombopag tablets - Treatment group 1 Herombopag placebo tablets - Treatment group 2 Herombopag tablets - Treatment group 2 Herombopag placebo tablets -
- Primary Outcome Measures
Name Time Method Part A: Vc/F 0 minute to 5 days Part A: Kin 0 minute to 35 days Part A: Kdeg 0 minute to 35 days Part A: CL/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: Kout 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 0 minute to 11 days Part B
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zhongshan Hospital, affiliated with Fudan University
🇨🇳Shanghai, Shanghai, China