Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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;