Actively Recruiting
Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery
Led by Anhui Provincial Hospital · Updated on 2024-11-05
60
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and willing to comply by signing informed consent
- Male or female, 18 years or older at consent
- Have chronic liver disease
- Baseline platelet count 35 x 10^9/L or lower before enrollment
- Scheduled elective invasive surgery that may need platelet transfusion, expected between days 9 and 15 after enrollment, excluding very high-risk surgeries
- Eastern Collaborative Oncology Group (ECOG) Physical Status score of 0 or 1
- Investigator believes participant can meet study requirements
- Male patients must be infertile or agree to use effective contraception from screening to post-treatment
- Female patients not menopausal or sterilized must agree to use highly effective contraception from screening to end of treatment
You will not qualify if you...
- Presence of haematopoietic tumors, aplastic anaemia, myelodysplastic syndrome, myelofibrosis, congenital thrombocytopenia, drug-induced thrombocytopenia, or immune thrombocytopenia
- Systemic infections needing treatment (except viral hepatitis)
- Solid malignancy requiring systemic chemotherapy, targeted therapy, immunotherapy, herbal medicine, or radiotherapy during study
- Malignancy with lymph node metastasis, distant metastasis, or peripheral organ invasion
- Exceptions: malignancy targeted by first invasive surgery, non-melanoma skin cancers, intramucosal cancers, carcinoma in situ without treatment needed
- History of liver transplantation
- Previous or current thrombosis or pre-thrombotic states including specific heart conditions
- Symptoms of severe hepatic encephalopathy or uncontrolled ascites
- Total bilirubin greater than 3 mg/dL
- History or evidence of bleeding disorders or coagulation deficiencies
- History or evidence of congenital or acquired thrombophilia or Budd-Chiari syndrome
- Portal vein tumor embolism or thrombosis
- Recent untreated gastro-oesophageal varices bleeding or need for treatment
- Bleeding score grade 2 or higher before enrollment
- Use of antineoplastic agents (except specified), interferon, radiotherapy, or experimental drugs within 90 days before enrollment
- Known allergy to study drugs
- Positive HIV test at screening
- Women who are pregnant or breastfeeding
- Investigator deems participant ineligible for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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