Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center

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

Study Overview

• Status: Recruiting
• Conditions: Hepatopathy
• Intervention / Treatment: Drug: Hetrombopag; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lu Wang, Professor; Phone Number: 18121299555; Email: wang.lu99@hotmail.com
• Study Contact Backup: Name: Ti Zhang, Professor; Phone Number: 15800680751; Email: zhangti@shca.org.cn

Study Locations

• China
  • Shanghai, China, 200062
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Lu Wang, M.D.; Phone Number: +86-15800680751; Email: w.lr@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 1; durg：Hetrombopag 5mg，once daily，oral	Drug: Hetrombopag; The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day
Experimental: Experimental: 2; Ndurg： Placebo 5mg，once daily，oral	Drug: Placebo; The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with bleeding after surgery need intervention.	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).	up to 7 days following surgery。
Incidence of deep venous thrombosis	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.	up to 3 months following surgery.
Incidence of liver failure	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.	up to 3 months following surgery.
Changes in preoperative Platelet count compared to baseline	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	baseline and up to 1 days prior to surgery
Proportion of patients whose Platelet count returned to ≥80×10^9/L	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.	baseline and up to 1 days prior to surgery

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Lu Wang, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: thrombocytopenia; Hepatopathy; Hetrombopag
• Additional Relevant MeSH Terms: Digestive System Diseases; Hematologic Diseases; Blood Platelet Disorders; Cytopenia; Liver Diseases; Thrombocytopenia
• Other Study ID Numbers: OBU-SH-HCC-II-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No