Chronic Liver DiseaseNCT06642740
Study on the Efficacy and Safety of Avatricopal in Patients With CLD Complicated With Thrombocytopenia
An observational study of Chronic Liver Disease and Thrombopenia, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
In this study, patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia were enrolled. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Thrombopenia
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 1 Jun 2025
- 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: Patients with chronic liver disease complicated with thrombocytopenia undergoing elective invasive and minimally invasive surgery were admitted to the experimental group for clinical observation.
Who may be able to join
- Voluntarily join the study and sign the informed consent;
- Age ≥18 years old, male or female;
- Baseline platelet count < 50×10^9/L;
- Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery;
- No fertility requirements.
Who cannot join
- History of arterial or venous thrombosis within 6 months prior to baseline;
- Plan to receive platelet transfusion or platelet-containing blood products within 7 days prior to baseline visit;
- Anticoagulant or antiplatelet therapy cannot be suspended before surgery according to the standard (low-dose aspirin is allowed to continue);
- currently receiving treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists (such as rhTPO, Etopopal, or romipristine);
- The subjects had severe arteriosclerosis, cerebral thrombosis tendency, coronary artery stenosis > 70%;
- Patients with a history of arterial or venous thrombosis within 6 months before enrollment;
Show all 13Show fewer
- Patients with known portal vein blood flow velocity < 10 cm/s or previous portal vein thrombosis within 6 months before enrollment;
- Prior to enrollment, any known primary blood history (e.g., immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
- A known history of hereditary prethrombotic syndrome prior to admission (e.g., VLeiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency);
- A history of major cardiovascular disease within the 6 months prior to enrollment (e.g., aggravated congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [such as atrial fibrillation], coronary or peripheral arterial stenting or angioplasty, and coronary or peripheral arterial bypass grafting);
- the subject is allergic to avatripopal or any of its excipients;
- Exclude vulnerable people with mental disorders and other disabilities
- The investigator believes that accompanying medical history may affect the safe completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
Official title: Study on the Efficacy and Safety of Avatricopal in Patients With Chronic Liver Disease With Selective Invasive and Minimally Invasive Surgery Combined With Thrombocytopenia
In this study, patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia were enrolled. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed.
Read the detailed description
This is a single-center, single-arm, prospective study. Patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. The baseline demographic data and biochemical data of the subjects were collected. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed. To investigate the efficacy and safety of avatripopal in chronic liver disease patients with thrombocytopenia undergoing elective invasive and minimally invasive surgery. To provide reference for related clinical treatment.
- Conditions
- Chronic Liver Disease, Thrombopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Platelet count: <50×10^9/L | Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery with concomitant thrombocytopenia, who meet the inclusion criteria and are treated with atorvastatin, were included in the study group for clinical observation. Eligibility for treatment, dosage selection (60 mg/day for PLT < 40×10^9/L, 40 mg/day for PLT 40-50×10^9/L), the standard treatment regimen of 5 consecutive days of oral administration, and timing of procedures (10 ± 3 days after treatment initiation) reflected routine clinical practice and were aligned with the drug's pharmacokinetic profile and prescribing information. Follow-up visits and data collection time points (baseline, day 5, day 10, and day 40) were standardized for the purposes of systematic data capture in this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
Measured: 2024-2025
Secondary outcomes (1)
Adverse event rate
Recent and long-term thrombotic events and bleeding events
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Yao Xie, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642740
- Sponsor's protocol ID
- DTXY29
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Avatricopal in Patients With Chronic Liver Disease With Selective Invasive and Minimally Invasive Surgery Combined With Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06642740
- Acronym / sponsor ID
- DTXY29
- Conditions
- Chronic Liver Disease, Thrombopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 15 Oct 2024 (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.
In this study, patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia were enrolled. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed.
Detailed description
This is a single-center, single-arm, prospective study. Patients with chronic liver disease undergoing selective invasive and minimally invasive surgery combined with thrombocytopenia. After enrollment, liver disease treatment was supplemented with avatripopal for 5 days. The baseline demographic data and biochemical data of the subjects were collected. Biochemical indexes of avatripopal were monitored during treatment and after withdrawal. The proportion of patients with platelet count ≥50×10^9/L on the day of selective invasive and minimally invasive surgery was analyzed. The incidence of adverse events was observed. To investigate the efficacy and safety of avatripopal in chronic liver disease patients with thrombocytopenia undergoing elective invasive and minimally invasive surgery. To provide reference for related clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet count: <50×10^9/L | – | –Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery with concomitant thrombocytopenia, who meet the inclusion criteria and are treated with atorvastatin, were included in the study group for clinical observation. Eligibility for treatment, dosage selection (60 mg/day for PLT < 40×10^9/L, 40 mg/day for PLT 40-50×10^9/L), the standard treatment regimen of 5 consecutive days of oral administration, and timing of procedures (10 ± 3 days after treatment initiation) reflected routine clinical practice and were aligned with the drug's pharmacokinetic profile and prescribing information. Follow-up visits and data collection time points (baseline, day 5, day 10, and day 40) were standardized for the purposes of systematic data capture in this observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease complicated with thrombocytopenia undergoing elective invasive and minimally invasive surgery were admitted to the experimental group for clinical observation.
Key inclusion criteria (5 listed)
- Voluntarily join the study and sign the informed consent;
- Age ≥18 years old, male or female;
- Baseline platelet count < 50×10^9/L;
- Patients with chronic liver disease undergoing elective invasive and minimally invasive surgery;
- No fertility requirements.
Key exclusion criteria (13 listed)
- History of arterial or venous thrombosis within 6 months prior to baseline;
- Plan to receive platelet transfusion or platelet-containing blood products within 7 days prior to baseline visit;
- Anticoagulant or antiplatelet therapy cannot be suspended before surgery according to the standard (low-dose aspirin is allowed to continue);
- currently receiving treatment with recombinant human thrombopoietin or thrombopoietin receptor agonists (such as rhTPO, Etopopal, or romipristine);
- The subjects had severe arteriosclerosis, cerebral thrombosis tendency, coronary artery stenosis > 70%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
Time frame: 2024-2025
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery.
1 secondary outcome
Adverse event rate
Time frame: 2024-2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
Yao Xie, Doctor principal investigator
Beijing Ditan Hospital
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 Chronic Liver Disease and Thrombopenia, run by Beijing Ditan 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 21 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with platelet count ≥50×10^9/L on the day of elective invasive and minimally invasive surgery. (time frame: 2024-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.