ThrombocytopeniaPhase 2NCT06673498
Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery
A Phase 2 study testing Lusutrombopag combined with recombinant human thrombopoietin in people with Thrombocytopenia, run by Anhui Provincial Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Lusutrombopag combined with recombinant human thrombopoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 10 Nov 2024to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Ability to understand the study and willingness to comply with all study procedures by voluntarily signing an informed consent form prior to screening.
- Male or female, 18 years of age or older at the time of signing the informed consent form.
- Patients with chronic liver disease.
- Baseline platelet count ≤ 35 x 109/L prior to enrolment on day 1.
- Proposed elective invasive surgery that meets the following conditions: - Platelet transfusion may be required - Expected to be performed between days 9 and 15 after enrolment - Excludes extremely high-risk surgical operations such as open abdomen, open chest, open skull, and direct cardiac surgery.
- Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 or 1.
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- According to the researcher, it will be able to fulfil the requirements of this study.
- Male patients who are infertile or who agree to use adequate contraception (including the use of condoms containing spermicides) from the start of screening until completion of the post-treatment phase.
- Female patients who are not menopausal or surgically sterilised need to agree to the use of highly effective contraception (including implants, injectable contraception, combined hormonal contraception [including vaginal rings], intrauterine devices, or partner-performed vasectomies) from the start of the screening until the completion of the end-of-treatment phase. The use of barrier contraception with or without spermicide, double barrier contraception and oral contraceptives alone is not adequate.
Who cannot join
- Presence of any of the following diseases: - Haematopoietic tumours - Aplastic anaemia - myelodysplastic syndrome - myelofibrosis - Congenital thrombocytopenia - Drug-induced thrombocytopenia - Immune thrombocytopenia - Systemic infections requiring treatment, except viral hepatitis
- Any solid malignancy with the following conditions: - Patients will require systemic chemotherapy, targeted therapy, immunotherapy, traditional herbal medicine or radiotherapy for that malignancy during the study period - Malignancy with lymph node metastasis, distant metastasis or peripheral organ invasion - Exceptions are: - Malignancy is a therapeutic target for the first invasive surgery - Non-melanoma skin cancers, intramucosal cancers, or carcinoma in situ that do not require any treatment during the study period.
- History of liver transplantation.
- Previous or current thrombosis or pre-thrombotic state (e.g., cerebral infarction, cardiac infarction, angina pectoris, coronary stenting, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association {NYHA} class III/IV], cardiac arrhythmia [e.g., atrial fibrillation] known to increase the risk of thromboembolic events, pulmonary thromboembolism, deep venous thrombosis, or disseminated vascular (intravascular coagulation syndrome).
- Presence of any of the following conditions at screening: - Symptoms of hepatic encephalopathy with Child-Pugh Hepatic Encephalopathy Score 3 (occasional coma), with or without treatment for hepatic encephalopathy - Ascites uncontrolled by medications - Total bilirubin > 3 mg/dL
- Presence of history or evidence of a disease with bleeding risk (e.g. coagulation factor deficiency or vascular haemophilia factor vWF deficiency).
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- History or evidence of any of the following disorders: - Congenital thrombophilia (e.g., antithrombin deficiency, protein C deficiency, protein S deficiency, or coagulation factor [coagulation factor V Leiden] mutation) - Acquired thrombophilia (e.g., antiphospholipid antibody syndrome, paroxysmal nocturnal haemoglobinuria, hyperhomocysteinemia, or elevated coagulation factor VIII) - Budd-Chiari syndrome
- Portal vein tumour embolism.
- Ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to enrolment showing portal vein thrombosis, or a history of portal vein thrombosis.
- Upper gastrointestinal endoscopy within 180 days prior to enrolment showing bleeding due to untreated gastro-oesophageal varices or the need to undergo treatment (except for patients in whom the first invasive procedure was performed to treat gastro-oesophageal varices).
- Prior to enrolment, the bleeding score was ≥ grade 2 according to the World Health Organization (WHO) Bleeding Scale.
- Use of any of the following medications or treatments within 90 days prior to enrolment: - Antineoplastic agents, excluding transcatheter arterial chemoembolisation (TACE) and oil iodide embolisation - Interferon agents - Radiotherapy - Radiotherapy - Any experimental drug
- Known hypersensitivity to the test drug or any of its excipients.
- Positive human immunodeficiency virus antigen/antibody test at screening.
- Women who are pregnant or breastfeeding.
- Patients deemed ineligible by the investigator for any other reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
No.2 People's Hospital of Fuyang city
Fuyang, Anhui, 236015
DaYong Luo, +86 13805587172, fyldy7172@sina.com
- Recruiting
Anhui province hospital
Hefei, Anhui, 230000
Ji-Zhou Wang, M.D., +86 13836135864, wangjoe@ustc.edu.cn
About this study
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: a Prospective, Multicentre, Single-arm Clinical Study
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
- Thrombocytopenia
- Being tested
- Lusutrombopag combined with recombinant human thrombopoietin
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lusutrombopag combined with recombinant human thrombopoietinDrug
After eligibility is confirmed, patients will begin treatment with Lusutrombopag +recombinant human thrombopoietin on Day 1, and study treatment will continue for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Lusutrombopag combined with recombinant human thrombopoietin Receives: Drug: Lusutrombopag combined with recombinant human thrombopoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of respondents at day 8
Responders were defined as subjects who achieved a platelet count of ≥50 × 10^9/L and an increase of ≥20 × 10^9/L from baseline and who did not receive emergency treatment for bleeding
Measured: Day 8
Secondary outcomes (4)
Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery
Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery
Measured: on or after day 8 and within 2 days prior to elective invasive surgery
Proportion of subjects meeting the definition of responder at any time during the study period
Responders were defined as subjects who achieved a platelet count of ≥50 × 10^9/L and an increase of ≥20 × 10^9/L from baseline and who did not receive emergency treatment for bleeding
Measured: Each routine blood test on or after day 8
Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
Measured: During the procedure
Number and dose of platelet transfusions during the study period
Number and dose of platelet transfusions during the study period
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lianxin Liu, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673498
- Sponsor's protocol ID
- 2024KY402
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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: a Prospective, Multicentre, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT06673498
- Acronym / sponsor ID
- 2024KY402
- Conditions
- Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Nov 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Lusutrombopag combined with recombinant human thrombopoietinLusutrombopag combined with recombinant human thrombopoietin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand the study and willingness to comply with all study procedures by voluntarily signing an informed consent form prior to screening.
- Male or female, 18 years of age or older at the time of signing the informed consent form.
- Patients with chronic liver disease.
- Baseline platelet count ≤ 35 x 109/L prior to enrolment on day 1.
- Proposed elective invasive surgery that meets the following conditions: - Platelet transfusion may be required - Expected to be performed between days 9 and 15 after enrolment - Excludes extremely high-risk surgical operations such as open abdomen, open chest, open skull, and direct cardiac surgery.
Key exclusion criteria (16 listed)
- Presence of any of the following diseases: - Haematopoietic tumours - Aplastic anaemia - myelodysplastic syndrome - myelofibrosis - Congenital thrombocytopenia - Drug-induced thrombocytopenia - Immune thrombocytopenia - Systemic infections requiring treatment, except viral hepatitis
- Any solid malignancy with the following conditions: - Patients will require systemic chemotherapy, targeted therapy, immunotherapy, traditional herbal medicine or radiotherapy for that malignancy during the study period - Malignancy with lymph node metastasis, distant metastasis or peripheral organ invasion - Exceptions are: - Malignancy is a therapeutic target for the first invasive surgery - Non-melanoma skin cancers, intramucosal cancers, or carcinoma in situ that do not require any treatment during the study period.
- History of liver transplantation.
- Previous or current thrombosis or pre-thrombotic state (e.g., cerebral infarction, cardiac infarction, angina pectoris, coronary stenting, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association {NYHA} class III/IV], cardiac arrhythmia [e.g., atrial fibrillation] known to increase the risk of thromboembolic events, pulmonary thromboembolism, deep venous thrombosis, or disseminated vascular (intravascular coagulation syndrome).
- Presence of any of the following conditions at screening: - Symptoms of hepatic encephalopathy with Child-Pugh Hepatic Encephalopathy Score 3 (occasional coma), with or without treatment for hepatic encephalopathy - Ascites uncontrolled by medications - Total bilirubin > 3 mg/dL
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 |
|---|---|---|
| Lusutrombopag combined with recombinant human thrombopoietinAfter eligibility is confirmed, patients will begin treatment with Lusutrombopag +recombinant human thrombopoietin on Day 1, and study treatment will continue for 7 days | Drug | Treatment group |
Primary outcome
Percentage of respondents at day 8
Time frame: Day 8
Responders were defined as subjects who achieved a platelet count of ≥50 × 10^9/L and an increase of ≥20 × 10^9/L from baseline and who did not receive emergency treatment for bleeding
4 secondary outcomes
Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery
Time frame: on or after day 8 and within 2 days prior to elective invasive surgery
Proportion of subjects meeting the definition of responder at any time during the study period
Time frame: Each routine blood test on or after day 8
Proportion of subjects requiring emergency treatment for bleeding at any time during the study period
Time frame: During the procedure
Number and dose of platelet transfusions during the study period
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Lianxin Liu principal investigator
Anhui Provincial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lusutrombopag combined with recombinant human thrombopoietin in people with Thrombocytopenia, run by Anhui Provincial Hospital at 2 sites 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Zhou Wang (+86 13836135864, wangjoe@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of respondents at day 8 (time frame: Day 8). 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 5 Nov 2024.