Actively Recruiting
Lusutrombopag Combined With Recombinant Human Thrombopoietin for Treating Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Surgery: A Prospective, Multicentre, Single-Arm Study
Led by Anhui Provincial Hospital · Updated on 2024-11-05
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of lusutrombopag combined with recombinant human thrombopoietin in treating thrombocytopenia in patients with chronic liver disease who are scheduled for elective invasive surgery. This Phase 2 study aims to assess both the safety and efficacy of this combined treatment approach in improving platelet counts before surgery. Participants will receive the combined treatment starting on the first day after eligibility is confirmed, continuing daily for seven days. The study focuses on patients undergoing planned surgeries expected to occur between days 9 and 15 after enrollment, excluding extremely high-risk surgeries such as open abdomen, chest, skull, or cardiac surgeries. During the study, participants will be monitored to measure the percentage of responders by day 8 and the proportion achieving sufficient platelet counts before surgery. Researchers will also track bleeding emergencies and the use of platelet transfusions during procedures. The total study duration includes treatment and observation around the surgical period, with safety and efficacy evaluated through routine blood tests and clinical assessments.
CONDITIONS
Brief Title
Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to follow study procedures by signing informed consent
- Male or female aged 18 years or older at consent
- Diagnosis of chronic liver disease
- Baseline platelet count 35 x 10^9/L or lower before enrollment
- Scheduled elective invasive surgery expected between days 9 and 15 after enrollment, excluding extremely high-risk surgeries
- Eastern Collaborative Oncology Group (ECOG) Physical Status score of 0 or 1
- Considered able by the researcher to meet study requirements
- Male patients infertile or agreeing to use effective contraception during study
- Female patients not menopausal or sterilized agreeing to use highly effective contraception during study
You will not qualify if you...
- Presence of haematopoietic tumors, aplastic anemia, myelodysplastic syndrome, myelofibrosis, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, or systemic infections requiring treatment except viral hepatitis
- Solid malignancies requiring systemic therapy during study or with metastasis or organ invasion, except certain skin or in situ cancers
- History of liver transplantation
- History or current thrombosis or pre-thrombotic conditions
- Severe hepatic encephalopathy, uncontrolled ascites, or high bilirubin levels
- History or evidence of bleeding risk diseases
- Congenital or acquired thrombophilia or Budd-Chiari syndrome
- Portal vein tumor embolism or thrombosis
- Recent bleeding from untreated gastro-oesophageal varices
- Severe bleeding score prior to enrollment
- Use of antineoplastic agents, interferon, radiotherapy, or experimental drugs within 90 days
- Known allergy to study drug or excipients
- Positive HIV test
- Pregnant or breastfeeding women
- Investigator deems participant ineligible for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive Lusutrombopag combined with recombinant human thrombopoietin for thrombocytopenia.
1 baseline visit and daily visits during treatment
Trial Site Locations
Total: 2 locations
1
No.2 People's Hospital of Fuyang city
Fuyang, Anhui, China, 236015
Actively Recruiting
2
Anhui province hospital
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
J
Ji-Zhou Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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