Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Lusutrombopag combined with recombinant human thrombopoietin

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ji-Zhou Wang; Phone Number: +86 13836135864; Email: wangjoe@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Fuyang, Anhui, China, 236015
      • Recruiting
      • NO.2 People's Hospital of Fuyang City
      • Contact: DaYong Luo; Phone Number: +86 13805587172; Email: fyldy7172@sina.com
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Province Hospital
      • Contact: Ji-Zhou Wang, M.D.; Phone Number: +86 13836135864; Email: wangjoe@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Lusutrombopag combined with recombinant human thrombopoietin	Drug: Lusutrombopag combined with recombinant human thrombopoietin; After eligibility is confirmed, patients will begin treatment with Lusutrombopag +recombinant human thrombopoietin on Day 1, and study treatment will continue for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Each routine blood test on or after day 8
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	During the procedure
Number and dose of platelet transfusions during the study period	Number and dose of platelet transfusions during the study period	During the procedure

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Lianxin Liu, Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Digestive System Diseases; Hematologic Diseases; Blood Platelet Disorders; Liver Diseases; Thrombocytopenia
• Other Study ID Numbers: 2024KY402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No