Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma
Efficacy and Safety of Avatrombopag in Thrombocytopenia in Patients With Primary Hepatocellular Carcinoma Undergoing Elective Hepatectomy: a Multicenter, Randomized, Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Jian Zhou, MD PhD
- Phone Number: 13801914007
- Email: zhou.jian@zs-hospital.sh.cn
Study Locations
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Shanghai, China
- Recruiting
- Zhongshan hospital, Fudan university
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Contact:
- Jian Zhou, MD PhD
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be able to understand this study and be willing to abide by all research procedures and sign informed consent voluntarily before screening;
- Male or female, at least 18 years old when signing informed consent;
- The initial clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were IA and IB;
- Before enrollment, baseline platelet count < 75×10^9/L and > 30×10^9/L;
- Elective hepatectomy is proposed, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation;
- Child-pugh GRADE A;
- HBsAg and/or anti-HCV positive;
- Male patients who are infertile or who agree to use appropriate contraceptive methods from the beginning of screening until the completion of the post-treatment phase;
- Women who have not undergone menopause or surgical sterilization need to agree to use highly effective contraception from the beginning of screening until the completion of the post-treatment phase;
- According to the opinions of researchers, those who can meet the requirements of this study.
Exclusion Criteria:
- Any diseases below: Solid malignancies other than hepatocellular carcinoma, blood system tumor, aplastic anemia, myelodysplastic syndrome, myelofibrosis, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, need treatment of systemic infection (except viral hepatitis);
- Always thrombosis or current or former state (such as cerebral infarction, myocardial infarction, angina pectoris, coronary artery carotid stenting and angioplasty, coronary artery bypass grafting, congestive heart failure, known to increase the risk of thromboembolic events of arrhythmias such as atrial fibrillation, pulmonary thromboembolism, deep vein thrombosis or diffuse intravascular coagulation syndrome).
- A known history of hereditary prethrombotic syndrome (e.g., clotting factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
- Transfusion of platelets or blood products containing platelets within 7 days prior to screening;
- Use erythropoietin within 7 days before screening;
- Rhil-11,rhTPO, TPO receptor agonists (such as Avatriprap, altrippal, or romistetine) or splenic embolization within 30 days prior to screening;
- Use of any of the following drugs or treatments within 90 days prior to screening: chemotherapy, interferon preparations, radiation;
- Patients requiring systemic chemotherapy, targeted therapy, immunotherapy, traditional Chinese herbal therapy or radiation therapy during the study period;
- At screening time, hemoglobin level ≤9.0g/dL or ≥18.0g/dL in male patients and > 15.0g/dL in female patients, and hematocrit in male ≥0.54 and female ≥0.45;
- Bleeding score ≥2 at screening (according to the WHO Bleeding scale);
- Pt-inr and APTT at screening were lower than 80% of the lower limit of normal range or higher than 120% of the upper limit of normal range;
- Preoperative anticoagulant or antiplatelet therapy should not be suspended according to the standard (low-dose aspirin is allowed to continue);
- Female subjects who are breast-feeding or pregnant at the time of screening, or who plan to become pregnant during the study period;
- Known or suspected persistent alcohol or drug abuse;
- Known allergy to Avatripopa or any of its excipients;
- HIV infected persons;
- Participate in another clinical study within 30 days prior to screening, using any exploratory drugs or devices;Allowed to participate in observational studies;
- The investigator believes that the accompanying medical history may affect the subjects' safe completion of the study;
- In the opinion of the investigator, there are any other factors that may not be suitable for inclusion or affect participation or completion of the study.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
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patients with primary hepatocellular carcinoma undergoing elective hepatectomy
The baseline platelet count before enrollment was < 75×10^9/L and > 30×10^9/L.The primary clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were Ia and Ib.An elective hepatectomy, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation.
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On the basis of conventional treatment, Avatrombopag was added, 30×10^9/L < platelet count < 50×10^9/L patients received Avatrombopag 60mg/d, 50×10^9/L≤ platelet count < 75×10^9/L patients received Avatrombopag 40mg/d for 5 consecutive days, and waited for a period of time after drug withdrawal.Surgery is expected to take place on day 10-13 of the initial dose.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of patients with a platelet count ≥75×10^9/L and an increase of platelet count more than 20% from baseline
Time Frame: on day 9-12 of treatment
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The Percentage of patients in the treatment group with platelet count ≥75×10^9/L (the highest test value of of platelet count was taken on day 9-12 of treatment) and an increase of platelet count more than 20% from baseline before operation.
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on day 9-12 of treatment
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Comparison of total amount of postoperative drainage fluid between treatment group and control group
Time Frame: on day 1-5 after surgery
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Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group
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on day 1-5 after surgery
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of intraoperative blood loss
Time Frame: During surgery
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Comparison of intraoperative blood loss between Treatment group and control group.
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During surgery
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Proportion of patients receiving remedial treatment due to bleeding risk after surgery
Time Frame: on day 0-30 after surgery
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Comparison of the proportion of patients receiving remedial treatment due to bleeding risk after surgery between the treatment group and the control group
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on day 0-30 after surgery
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Indwelling time of drainage tube
Time Frame: on day 0-10 after surgery
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Comparison of postoperative indwelling time of drainage tube between treatment group and control group
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on day 0-10 after surgery
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Red blood cell count and hemoglobin content of drainage fluid
Time Frame: on day 1-5 after surgery
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Comparison of red blood cell count and hemoglobin content of drainage fluid between treatment group and control group on the 1st, 3rd and 5th day after operation
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on day 1-5 after surgery
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Postoperative hospitalization time
Time Frame: on 0-30 day after surgery
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Comparison of postoperative hospitalization time between treatment group and control group
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on 0-30 day after surgery
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Preoperative platelet count increase from baseline
Time Frame: before surgery
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Preoperative platelet count increase from baseline in treatment group.
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before surgery
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The change of platelet count from baseline at different time points
Time Frame: through study completion, an average of 1 year
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The change of platelet count from baseline at different time points in the treatment group.
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jian Zhou, MD PhD, Fudan University
Publications and helpful links
General Publications
- Miller JB, Figueroa EJ, Haug RM, Shah NL. Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. Gastroenterol Hepatol (N Y). 2019 Jun;15(6):326-332.
- Li J, Han B, Li H, Deng H, Mendez-Sanchez N, Guo X, Qi X. Association of coagulopathy with the risk of bleeding after invasive procedures in liver cirrhosis. Saudi J Gastroenterol. 2018 Jul-Aug;24(4):220-227. doi: 10.4103/sjg.SJG_486_17.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SKX-2005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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