Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Conditions
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.
Interventions
DRUGHerombopag tablets
Herombopag tablets; dose 1 or dose 2, for 5 days
DRUGHerombopag placebo tablets
Herombopag placebo tablets; dose 1 or dose 2, for 5 days
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Herombopag compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0 minute to 11 days | Part B |
Secondary
| 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 |
Countries
China
Outcome results
None listed