Clinical trial NCT06673498: Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery
Official title: Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery: a Prospective, Multicentre, Single-arm Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Thrombocytopenia
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Proposed elective invasive surgery that meets the following conditions: - Platelet transfusion may be required - Expected to be performed between days 9 and 15 after enrolment - Excludes extremely high-risk surgical operations such as open abdomen, open chest, open skull, and direct cardiac surgery.
* Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 or 1.
* According to the researcher, it will be able to fulfil the requirements of this study.
* Male patients who are infertile or who agree to use adequate contraception (including the use of condoms containing spermicides) from the start of screening until completion of the post-treatment phase.
* Female patients who are not menopausal or surgically sterilised need to agree to the use of highly effective contraception (including implants, injectable contraception, combined hormonal contraception \[including vaginal rings\], intrauterine devices, or partner-performed vasectomies) from the start of the screening until the completion of the end-of-treatment phase. The use of barrier contraception with or without spermicide, double barrier contraception and oral contraceptives alone is not adequate.

Exclusion Criteria:

* 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).
* Presence of any of the following conditions at screening: - Symptoms of hepatic encephalopathy with Child-Pugh Hepatic Encephalopathy Score 3 (occasional coma), with or without treatment for hepatic encephalopathy - Ascites uncontrolled by medications - Total bilirubin \> 3 mg/dL
* Presence of history or evidence of a disease with bleeding risk (e.g. coagulation factor deficiency or vascular haemophilia factor vWF deficiency).
* History or evidence of any of the following disorders: - Congenital thrombophilia (e.g., antithrombin deficiency, protein C deficiency, protein S deficiency, or coagulation factor \[coagulation factor V Leiden\] mutation) - Acquired thrombophilia (e.g., antiphospholipid antibody syndrome, paroxysmal nocturnal haemoglobinuria, hyperhomocysteinemia, or elevated coagulation factor VIII) - Budd-Chiari syndrome
* Portal vein tumour embolism.
* Ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to enrolment showing portal vein thrombosis, or a history of portal vein thrombosis.
* Upper gastrointestinal endoscopy within 180 days prior to enrolment showing bleeding due to untreated gastro-oesophageal varices or the need to undergo treatment (except for patients in whom the first invasive procedure was performed to treat gastro-oesophageal varices).
* Prior to enrolment, the bleeding score was ≥ grade 2 according to the World Health Organization (WHO) Bleeding Scale.
* Use of any of the following medications or treatments within 90 days prior to enrolment: - Antineoplastic agents, excluding transcatheter arterial chemoembolisation (TACE) and oil iodide embolisation - Interferon agents - Radiotherapy - Radiotherapy - Any experimental drug
* Known hypersensitivity to the test drug or any of its excipients.
* Positive human immunodeficiency virus antigen/antibody test at screening.
* Women who are pregnant or breastfeeding.
* Patients deemed ineligible by the investigator for any other reason.

Primary outcomes:
measure: Percentage of respondents at day 8
timeFrame: Day 8
Secondary outcomes:
measure: 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
timeFrame: on or after day 8 and within 2 days prior to elective invasive surgery
measure: Proportion of subjects meeting the definition of responder at any time during the study period
timeFrame: Each routine blood test on or after day 8
measure: Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
timeFrame: During the procedure
measure: Number and dose of platelet transfusions during the study period
timeFrame: During the procedure
Other outcomes:
Locations:
city: Fuyang
country: China
facility: No.2 People's Hospital of Fuyang city
state: Anhui
city: Hefei
country: China
facility: Anhui province hospital
state: Anhui
Study officials:
affiliation: Anhui Provincial Hospital
name: Lianxin Liu
role: PRINCIPAL_INVESTIGATOR
References: