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Trial Title:
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy
NCT ID:
NCT05575986
Condition:
Malignant Tumors of the Digestive System
Trombocitopenia
Conditions: Official terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hetrombopag Olamine
Description:
Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken
on an empty stomach, 2 hours after oral administration before eating, avoid taking it
with meals.
Arm group label:
Observation group
Summary:
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia
after chemotherapy in patients with digestive system malignant tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate in clinical research and sign informed consent;
2. Age ≥18 years;
3. Digestive system malignancy confirmed by histology or cytology; Having used
oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy
regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and
≤75×109/L;
4. At least 10 days between TPO, IL-11 or platelet transfusion;
5. ECOG 0 to 2 points;
6. Expected survival time > 3 months;
7. Sufficient organ function for subsequent chemotherapy;
8. Women of reproductive age must be willing to use adequate contraception during the
study of drug treatment.
Exclusion Criteria:
1. Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months
before screening, including but not limited to EDTA-dependent
pseudothrombocytopenia, hypersplenism, infection, and bleeding;
2. Have any hematological malignancies, including leukemia, myeloma, bone marrow
proliferative diseases, lymphoma or bone marrow proliferative diseases;
3. Clinically significant acute or active bleeding within the week prior to screening;
4. Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden
mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII)
deficiency)
5. The subject has a history of major cardiovascular disease (e.g., congestive heart
failure (New York Heart Association Class 3/ cardiac function), known arrhythmias
(e.g., atrial fibrillation) that increase the risk of thromboembolic events,
coronary stenting, angioplasty, or coronary artery bypass grafting);
6. Subjects had a history of arterial or venous thrombosis within 3 months before
screening;
7. Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa
inhibitor, or thrombin inhibitor) within 7 days prior to screening;
8. The subject has a history of chronic platelet or hemorrhagic disorders, or
thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune
thrombocytopenic purpura);
9. TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
10. Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine,
etc.)
11. Those who cannot be treated with oral drugs;
12. Allergic to hetrombopag or any excipient;
13. Those whose organ function could not tolerate further antitumor therapy as assessed
by the investigator; This product is not recommended for use or discontinuation of
treatment in patients who meet any of the following criteria for liver function
ALT and AST > 8 x ULN.
ALT or AST>5×ULN for 2 weeks;
ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5);
ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain
or tenderness, fever, rash, and/or eosinophilia (>5%).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
xianglin Yuan
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
xianglin Yuan, doctor
Phone:
13667241722
Email:
yuanxianglin@hust.edu.cn
Start date:
October 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05575986
