Clinical trial NCT06507436: The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Herombopag compared with placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part A: CL/F
timeFrame: 0 minute to 5 days
measure: Part A: Vc/F
timeFrame: 0 minute to 5 days
measure: Part A: ka
timeFrame: 0 minute to 5 days
measure: Part A: Q/F
timeFrame: 0 minute to 5 days
measure: Part A: AUC0-tau
timeFrame: 0 minute to 5 days
measure: Part A: Cmax
timeFrame: 0 minute to 5 days
measure: Part A: Kin
timeFrame: 0 minute to 35 days
measure: Part A: Kout
timeFrame: 0 minute to 35 days
measure: Part A: Kdeg
timeFrame: 0 minute to 35 days
measure: Part A: Slope
timeFrame: 0 minute to 35 days
measure: 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
timeFrame: 0 minute to 11 days
Secondary outcomes:
measure: The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery
timeFrame: 0 minute to 11 days
measure: The duration of time during the study when the platelet count remains ≥50×10^9/L
timeFrame: 0 minute to 35 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, affiliated with Fudan University
state: Shanghai
Study officials:
References: