Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Phase 2

Recruiting

• Conditions: Hepatopathy
• Interventions: Drug: Placebo; Drug: Hetrombopag

• Registration Number: NCT05442632
• Lead Sponsor: Fudan University

Brief Summary

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

Detailed Description

The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Study Start: 2022-07-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 1. Male and female subjects ≥18 years of age；
• 2.Patients prepared to receive hepatectomy；
• 3.50×10^9/L≤platelet count≤80×10^9/L；
• 4.Child-PUgh score A or grade B (≤7 )；
• 5.Life expectancy ≥3 months；
• 6.Normal Bone marrow hematopoiesis and renal function;
• 7.Voluntary participation and written informed consent;

Exclusion Criteria

• 1.Central nervous system diseases caused by liver disease;
• 2.Platelet transfusion within 7 days prior to the first dose of study drug;
• 3.History of any primary hematologic disorder;
• 4.History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
• 5.Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
• 6.History of Myelodysplastic Syndrome (MDS);
• 7.Those with bleeding tendency，have evidence of hereditary bleeding or blood coagulation disorder;
• 8.Females who are pregnant (positive β-hCG test ) or breastfeeding;
• 9.Subjects who have participated in another investigational trial within 30 days prior to Visit 1;
• 10.Those with uncontrollable neurological and psychiatric diseases or mental disorders, poor compliance, unable to cooperate and describe treatment response;
• 11.Subjects with known intolerance or allergy to any of the ingredients in eltrombopag tablets;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: 2	Placebo	Ndurg： Placebo 5mg，once daily，oral
Experimental: 1	Hetrombopag	durg：Hetrombopag 5mg，once daily，oral

Primary Outcome Measures

Name	Time	Method
The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period	From the start of using the investigational drug to 7 days after surgery completion	Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.

Secondary Outcome Measures

Name	Time	Method
Incidence of deep venous thrombosis	up to 3 months following surgery.	Imaging examination will be conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery, to evaluate deep venous thrombosis if necessary.
Proportion of patients with bleeding after surgery need intervention.	up to 7 days following surgery。	The World Health Organization Bleeding Scale was used to assess bleeding following surgery.. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small \[1-2 millimeter\] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).
Proportion of patients whose Platelet count returned to ≥80×10^9/L	baseline and up to 1 days prior to surgery	Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated.
Changes in preoperative Platelet count compared to baseline	baseline and up to 1 days prior to surgery	Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated
Incidence of liver failure	up to 3 months following surgery.	Posthepatectomy liver failure is defined as: A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio and hyperbilirubinemia on or after postoperative day 5. If international normalized ratio or serum bilirubin concentration is increased preoperatively, Post hepatectomy liver failure is defined by an increasing international normalized ratio and increasing serum bilirubin concentration on or after postoperative day 5 Other obvious causes for the observed biochemical and clinical alterations such as biliary obstruction should be ruled out. The evaluate of liver failure was conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China