ThrombocytopeniaNCT05087459
Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma
An observational study of Thrombocytopenia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Avatrombopag
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective hepatectomy with thrombocytopenia in adults with primary hepatocellular carcinoma
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan University
Shanghai
Jian Zhou, MD PhD
About this study
Official title: Efficacy and Safety of Avatrombopag in Thrombocytopenia in Patients With Primary Hepatocellular Carcinoma Undergoing Elective Hepatectomy: a Multicenter, Randomized, Controlled Study
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and liver transplantation.Chronic liver disease caused by hepatitis B infection is the main pathogenic factor of liver cancer in China. Meanwhile, nearly 80% of patients with hepatocellular carcinoma are complicated with cirrhosis, and the incidence of thrombocytopenia in patients with cirrhosis is reported to be as high as 78%.Many previous studies have found that thrombocytopenia is closely related to perioperative outcome of hepatocellular carcinoma.The purpose of this study was to evaluate the efficacy and safety of avatripopa in the treatment of thrombocytopenia in patients with primary hepatocellular carcinoma undergoing elective hepatectomy and its effect on perioperative outcome.
Read the detailed description
The indicators included changes in platelet count before and after drug treatment and operation, the nature and amount of postoperative drainage (ascites), duration of indwelling drainage tube, intraoperative blood loss, perioperative complications, length of hospital stay, etc.After comprehensive consideration of all perioperative indicators, we selected the total amount of drainage (ascites) multiple days after surgery as the primary outcome.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag
- Keywords
- Avatrombopag, Primary hepatocellular carcinoma, elective hepatectomy
- Medical subject headings
- Thrombocytopenia, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Also called Doptelet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Avatrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a platelet count ≥75×10^9/L and an increase of platelet count more than 20% from baseline
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.
Measured: on day 9-12 of treatment
Comparison of total amount of postoperative drainage fluid between treatment group and control group
Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group
Measured: on day 1-5 after surgery
Secondary outcomes (7)
Comparison of intraoperative blood loss
Comparison of intraoperative blood loss between Treatment group and control group.
Measured: During surgery
Proportion of patients receiving remedial treatment due to bleeding risk after surgery
Comparison of the proportion of patients receiving remedial treatment due to bleeding risk after surgery between the treatment group and the control group
Measured: on day 0-30 after surgery
Indwelling time of drainage tube
Comparison of postoperative indwelling time of drainage tube between treatment group and control group
Measured: on day 0-10 after surgery
Red blood cell count and hemoglobin content of drainage fluid
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
Measured: on day 1-5 after surgery
Postoperative hospitalization time
Comparison of postoperative hospitalization time between treatment group and control group
Measured: on 0-30 day after surgery
Preoperative platelet count increase from baseline
Preoperative platelet count increase from baseline in treatment group.
Measured: before surgery
The change of platelet count from baseline at different time points
The change of platelet count from baseline at different time points in the treatment group.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Jun 2021
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, MD PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087459
- Sponsor's protocol ID
- SKX-2005
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31391802Li 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.
PubMed 29956689
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Avatrombopag in Thrombocytopenia in Patients With Primary Hepatocellular Carcinoma Undergoing Elective Hepatectomy: a Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05087459
- Acronym / sponsor ID
- SKX-2005
- Conditions
- Thrombocytopenia
- Keywords
- Avatrombopag, Primary hepatocellular carcinoma, elective hepatectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and liver transplantation.Chronic liver disease caused by hepatitis B infection is the main pathogenic factor of liver cancer in China. Meanwhile, nearly 80% of patients with hepatocellular carcinoma are complicated with cirrhosis, and the incidence of thrombocytopenia in patients with cirrhosis is reported to be as high as 78%.Many previous studies have found that thrombocytopenia is closely related to perioperative outcome of hepatocellular carcinoma.The purpose of this study was to evaluate the efficacy and safety of avatripopa in the treatment of thrombocytopenia in patients with primary hepatocellular carcinoma undergoing elective hepatectomy and its effect on perioperative outcome.
Detailed description
The indicators included changes in platelet count before and after drug treatment and operation, the nature and amount of postoperative drainage (ascites), duration of indwelling drainage tube, intraoperative blood loss, perioperative complications, length of hospital stay, etc.After comprehensive consideration of all perioperative indicators, we selected the total amount of drainage (ascites) multiple days after surgery as the primary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with primary hepatocellular carcinoma undergoing elective hepatectomy | – | Drug: AvatrombopagThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective hepatectomy with thrombocytopenia in adults with primary hepatocellular carcinoma
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvatrombopagAlso: DopteletOn 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. | Drug | patients with primary hepatocellular carcinoma undergoing elective hepatectomy |
Primary outcome
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
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.
Comparison of total amount of postoperative drainage fluid between treatment group and control group
Time frame: on day 1-5 after surgery
Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group
7 secondary outcomes
Comparison of intraoperative blood loss
Time frame: During surgery
Proportion of patients receiving remedial treatment due to bleeding risk after surgery
Time frame: on day 0-30 after surgery
Indwelling time of drainage tube
Time frame: on day 0-10 after surgery
Red blood cell count and hemoglobin content of drainage fluid
Time frame: on day 1-5 after surgery
Postoperative hospitalization time
Time frame: on 0-30 day after surgery
Preoperative platelet count increase from baseline
Time frame: before surgery
The change of platelet count from baseline at different time points
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 31391802Miller 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.
- Background: PubMed 29956689Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhou, MD PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhou, MD PhD (13801914007, zhou.jian@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.