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Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
RECRUITINGPhase 2Sponsored by Fudan University
Actively Recruiting
PhasePhase 2
SponsorFudan University
Started2022-07-25
Est. completion2025-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05442632
Summary
This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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;
Conditions4
CancerHepatopathyLiver CancerLiver Disease
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Actively Recruiting
PhasePhase 2
SponsorFudan University
Started2022-07-25
Est. completion2025-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05442632