Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Hepatopathy

Treatments: Drug: Hetrombopag; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05442632

OBU-SH-HCC-II-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Experimental: 1

Experimental group

Description:

durg：Hetrombopag 5mg，once daily，oral

Treatment:

Drug: Hetrombopag

Experimental: 2

Experimental group

Description:

Ndurg： Placebo 5mg，once daily，oral

Treatment:

Drug: Placebo