Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Launched by FUDAN UNIVERSITY · Jun 30, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a medication called Herombopag for patients who have low platelet counts (a condition known as thrombocytopenia) and are preparing for liver surgery (hepatectomy). The study aims to see if this drug can help increase platelet levels before surgery, which is important because low platelet counts can lead to bleeding complications during and after the operation.

To participate in this trial, individuals must be at least 18 years old, have a platelet count between 50 and 80 billion per liter, and be in decent overall health with a life expectancy of at least three months. They should also be willing to give their consent to join the study. However, certain people will not be eligible, such as those with specific blood disorders or recent surgeries involving blood transfusions. Participants will receive the study medication and will be closely monitored for any effects. This trial is currently recruiting participants, and it's important for anyone interested to discuss with their healthcare provider to see if they qualify.

Gender

ALL

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;