Evaluating Herombopag for Increasing Platelet Counts Before Liver Surgery

Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center

This study is testing if a medication called Herombopag can help raise platelet counts in patients with low platelets before liver surgery to reduce the need for blood transfusions.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05442632 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the efficacy and safety of Herombopag in patients with thrombocytopenia who are scheduled for hepatectomy. It is a single-center, randomized, controlled study that aims to determine whether Herombopag can elevate platelet counts, thereby reducing the need for platelet transfusions before, during, and after the surgical procedure. The study will monitor the proportion of participants who avoid transfusions, as well as any bleeding events and safety issues for up to three months post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with thrombocytopenia who are preparing for hepatectomy.

Not a fit: Patients with central nervous system diseases due to liver disease or those with a history of primary hematologic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the need for platelet transfusions in patients undergoing liver surgery, improving surgical outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing thrombocytopenia, suggesting potential for success in this trial.

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;

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Lu Wang, Professor — Fudan University
• Study coordinator: Lu Wang, Professor

Conditions Hepatopathy; thrombocytopenia; Hetrombopag