Clinical trial NCT05442632: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatopathy
Keywords: Hepatopathy
thrombocytopenia
Hetrombopag
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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≤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;

Primary outcomes:
measure: The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period
timeFrame: From the start of using the investigational drug to 7 days after surgery completion
Secondary outcomes:
measure: Proportion of patients with bleeding after surgery need intervention.
timeFrame: up to 7 days following surgery。
measure: Changes in preoperative Platelet count compared to baseline
timeFrame: baseline and up to 1 days prior to surgery
measure: Proportion of patients whose Platelet count returned to ≥80×10^9/L
timeFrame: baseline and up to 1 days prior to surgery
measure: Incidence of deep venous thrombosis
timeFrame: up to 3 months following surgery.
measure: Incidence of liver failure
timeFrame: up to 3 months following surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Lu Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: