Study on the Efficacy and Safety of Avatricopal in Patients With CLD Complicated With Thrombocytopenia

Launched by BEIJING DITAN HOSPITAL · Oct 14, 2024

Keywords

ClinConnect Summary

This is a prospective, single-center observational study at Beijing Ditan Hospital looking at whether the drug avatripopal can help people with chronic liver disease and low platelets (thrombocytopenia) have enough platelets for planned invasive or minimally invasive surgery. All enrolled participants receive avatripopal for 5 days, with blood tests and safety checks during treatment and after it ends. The main question is how many people will have a platelet count of at least 50 x 10^9/L on the day of surgery. The study will also track adverse events, including bleeding or clotting.

Who may be eligible: adults 18 and older with chronic liver disease and platelet counts below 50 x 10^9/L who are planning elective surgery. About 69 people are planned to enroll, and the study is currently enrolling by invitation at a single center (Beijing Ditan Hospital). There are many exclusion rules, such as recent blood clots, plans for platelet transfusion around surgery, certain anticoagulant therapies that can’t be paused, allergies to avatripopal, and other health issues that could affect safety. There are two dosing groups based on baseline platelets: if platelets are less than 40 x 10^9/L, the dose is 60 mg/day; if platelets are 40–50 x 10^9/L, the dose is 40 mg/day. This is not a randomized trial and is not FDA-regulated.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily join the study and sign the informed consent;
• • Age ≥18 years old, male or female;
• • Baseline platelet count \< 50×10\^9/L;
• • Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery;
• • No fertility requirements.
• Exclusion Criteria:
• • History of arterial or venous thrombosis within 6 months prior to baseline;
• • Plan to receive platelet transfusion or platelet-containing blood products within 7 days prior to baseline visit;
• • Anticoagulant or antiplatelet therapy cannot be suspended before surgery according to the standard (low-dose aspirin is allowed to continue);
• • currently receiving treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists (such as rhTPO, Etopopal, or romipristine);
• • The subjects had severe arteriosclerosis, cerebral thrombosis tendency, coronary artery stenosis \> 70%;
• • Patients with a history of arterial or venous thrombosis within 6 months before enrollment;
• • Patients with known portal vein blood flow velocity \< 10 cm/s or previous portal vein thrombosis within 6 months before enrollment;
• • Prior to enrollment, any known primary blood history (e.g., immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
• • A known history of hereditary prethrombotic syndrome prior to admission (e.g., VLeiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
• • A history of major cardiovascular disease within the 6 months prior to enrollment (e.g., aggravated congestive heart failure, arrhythmias known to increase the risk of thromboembolic events \[such as atrial fibrillation\], coronary or peripheral arterial stenting or angioplasty, and coronary or peripheral arterial bypass grafting);
• • the subject is allergic to avatripopal or any of its excipients;
• • Exclude vulnerable people with mental disorders and other disabilities
• • The investigator believes that accompanying medical history may affect the safe completion of the study.