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Not Yet Recruiting NCT07925398

Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study

Conditions: Thrombocytopenia, Hepatic Interventional Procedure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 108
Sponsor: Zhongda Hospital

Summary

This is a prospective, multicenter, open-label, randomized controlled clinical study. It includes three phases: screening period, treatment period and follow-up period. A total of 108 adult patients with thrombocytopenia (PLT \< 50×10⁹/L) scheduled for elective hepatic interventional procedures will be enrolled.

Eligibility Criteria

Inclusion Criteria: * Patients aged ≥ 18 years * Child-Pugh class A or B * Baseline platelet count (PLT) \< 50 × 10⁹/L * Scheduled for elective liver interventional procedures meeting the following criteria: performed between Day 7 and Day 15 after enrollment, including mainly transvascular interventional procedures (TACE/HAIC ± systemic anti-tumor therapy, TAE, Yttrium-90 radioembolization, TIPS, PTVE, etc.) and percutaneous non-vascular interventional procedures (RFA, MWA, cryoablation, liver biopsy, etc.) * ECOG performance status 0 or 1 * Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and must agree to use effective contraception throughout the study period and for 7 days after the last dose of study drug * Voluntarily participating in this study, providing signed informed consent, and having good compliance Exclusion Criteria: * Presence of other diseases that may cause thrombocytopenia, including but not limited to: aplastic anemia, myelodysplastic syndromes, chronic myeloproliferative neoplasms, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, thrombocytopenia secondary to rheumatic immune diseases, etc. * Previous or current arterial or venous thrombosis, including partial or complete thrombosis * History of portal vein thrombosis and/or main portal vein tumor thrombus; and/or evidence of portal vein thrombosis on ultrasound, CT, or MRI during screening; and/or absence of hepatopetal portal venous flow on Doppler ultrasound; and/or portal venous flow velocity \< 10 cm/s * Scheduled for open abdominal surgery such as hepatectomy or liver transplantation * Received platelet-increasing procedures within 90 days prior to randomization, including partial splenic artery embolization, splenic radiofrequency/microwave ablation, high-intensity focused ultrasound (HIFU) of the spleen, three-dimensional conformal therapy of the spleen, etc. * Previous history of liver transplantation or splenectomy * At screening, any of the following: significant liver function abnormality with ALT/AST \>3×ULN or TBL \>2×ULN; hepatic encephalopathy with Child-Pugh hepatic encephalopathy score of 3 (occasional coma), irrespective of hepatic encephalopathy treatment; medication-refractory ascites * Bleeding score ≥ grade 2 according to the WHO bleeding scale prior to randomization, or history or evidence of diseases with bleeding risk * Received platelet transfusion or platelet-containing blood products (excluding red blood cells) within 3 days prior to randomization * Received any of the following medications within 14 days prior to randomization: TPO (e.g., rhTPO), other TPO-RA agents, recombinant human interleukin-11 (IL-11), etc. * Any other condition deemed unsuitable for inclusion in the study by the investigator

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07925398). StuddyBuddy aggregates publicly available trial information.