Back to resultsEfficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
Primary Purpose
Hepatopathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hetrombopag
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatopathy focused on measuring Hepatopathy, thrombocytopenia, Hetrombopag
Eligibility Criteria
Inclusion Criteria:
- 1. Male and female subjects ≥18 years of age；
- 2.Patients prepared to receive hepatectomy；
- 3.50×10^9/L≤platelet count≤100×10^9/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;
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: 1
Experimental: 2
Arm Description
durg：Hetrombopag 5mg，once daily，oral
Ndurg： Placebo 5mg，once daily，oral
Outcomes
Primary Outcome Measures
Proportion of patients need perioperative platelet transfusions.
Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.
Secondary Outcome Measures
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).
Prothrombin time、Activated partial thromboplastin time Change from baseline to prior to surgery
Prothrombin time、Activated partial thromboplastin time were determined from blood draws and collected on baseline and prior to 1 days of surgery.
Proportion of patients whose Platelet count returned to ≥100×10^9/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.
Mean platelet volume change from baseline to prior to surgery.
platelet volume were determined from blood draws, and collected on baseline and prior to 1 days of 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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442632
Brief Title
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
Official Title
Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Anticipated)
Primary Completion Date
August 4, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatopathy
Keywords
Hepatopathy, thrombocytopenia, Hetrombopag
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: 1
Arm Type
Experimental
Arm Description
durg：Hetrombopag 5mg，once daily，oral
Arm Title
Experimental: 2
Arm Type
Experimental
Arm Description
Ndurg： Placebo 5mg，once daily，oral
Intervention Type
Drug
Intervention Name(s)
Hetrombopag
Intervention Description
The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day
Primary Outcome Measure Information:
Title
Proportion of patients need perioperative platelet transfusions.
Description
Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.
Time Frame
Prior to 5 days up to 14 days following surgery
Secondary Outcome Measure Information:
Title
Proportion of patients with bleeding after surgery need intervention.
Description
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).
Time Frame
up to 7 days following surgery。
Title
Prothrombin time、Activated partial thromboplastin time Change from baseline to prior to surgery
Description
Prothrombin time、Activated partial thromboplastin time were determined from blood draws and collected on baseline and prior to 1 days of surgery.
Time Frame
baseline and up to 1 days prior to surgery
Title
Proportion of patients whose Platelet count returned to ≥100×10^9/L
Description
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.
Time Frame
baseline and up to 1 days prior to surgery
Title
Mean platelet volume change from baseline to prior to surgery.
Description
platelet volume were determined from blood draws, and collected on baseline and prior to 1 days of surgery.
Time Frame
baseline and up to 1 days prior to surgery
Title
Incidence of deep venous thrombosis
Description
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.
Time Frame
up to 3 months following surgery.
Title
Incidence of liver failure
Description
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.
Time Frame
up to 3 months following surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects ≥18 years of age；
2.Patients prepared to receive hepatectomy；
3.50×10^9/L≤platelet count≤100×10^9/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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Wang, Professor
Phone
18121299555
Email
wang.lu99@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ti Zhang, Professor
Phone
15800680751
Email
zhangti@shca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Wang, Professor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang, M.D.
Phone
+86-15800680751
Email
w.lr@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
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