To assess the efficacy and safety of lusutrombopag combined with recombinant human thrombopoietin for the treatment of thrombocytopenia in patients with chronic liver disease destined to undergo elective invasive surgery.
Ability to understand the study and willingness to comply with all study procedures by voluntarily signing an informed consent form prior to screening.
Male or female, 18 years of age or older at the time of signing the informed consent form.
Patients with chronic liver disease.
Baseline platelet count ≤ 35 x 109/L prior to enrolment on day 1.
Presence of any of the following diseases: - Haematopoietic tumours - Aplastic anaemia - myelodysplastic syndrome - myelofibrosis - Congenital thrombocytopenia - Drug-induced thrombocytopenia - Immune thrombocytopenia - Systemic infections requiring treatment, except viral hepatitis
Any solid malignancy with the following conditions: - Patients will require systemic chemotherapy, targeted therapy, immunotherapy, traditional herbal medicine or radiotherapy for that malignancy during the study period - Malignancy with lymph node metastasis, distant metastasis or peripheral organ invasion - Exceptions are: - Malignancy is a therapeutic target for the first invasive surgery - Non-melanoma skin cancers, intramucosal cancers, or carcinoma in situ that do not require any treatment during the study period.
History of liver transplantation.
Previous or current thrombosis or pre-thrombotic state (e.g., cerebral infarction, cardiac infarction, angina pectoris, coronary stenting, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association {NYHA} class III/IV], cardiac arrhythmia [e.g., atrial fibrillation] known to increase the risk of thromboembolic events, pulmonary thromboembolism, deep venous thrombosis, or disseminated vascular (intravascular coagulation syndrome).
Single group
Lusutrombopag combined with recombinant human thrombopoietin
DrugAfter eligibility is confirmed, patients will begin treatment with Lusutrombopag +recombinant human thrombopoietin on Day 1, and study treatment will continue for 7 days
Percentage of respondents at day 8
Responders were defined as subjects who achieved a platelet count of ≥50 × 10\^9/L and an increase of ≥20 × 10\^9/L from baseline and who did not receive emergency treatment for bleeding
Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery
Proportion of subjects achieving a platelet count ≥50 × 10\^9/L on or after day 8 and within 2 days prior to elective invasive surgery
Proportion of subjects meeting the definition of responder at any time during the study period
Responders were defined as subjects who achieved a platelet count of ≥50 × 10\^9/L and an increase of ≥20 × 10\^9/L from baseline and who did not receive emergency treatment for bleeding
Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
Number and dose of platelet transfusions during the study period
Number and dose of platelet transfusions during the study period
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