Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy (hetrombopag)
Primary Purpose
Malignant Tumors of the Digestive System, Trombocitopenia
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hetrombopag Olamine
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Tumors of the Digestive System
Eligibility Criteria
Inclusion Criteria:
- Volunteer to participate in clinical research and sign informed consent;
- Age ≥18 years;
- 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;
- At least 10 days between TPO, IL-11 or platelet transfusion;
- ECOG 0 to 2 points;
- Expected survival time > 3 months;
- Sufficient organ function for subsequent chemotherapy;
- Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.
Exclusion Criteria:
- 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;
- Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
- Clinically significant acute or active bleeding within the week prior to screening;
- Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
- 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);
- Subjects had a history of arterial or venous thrombosis within 3 months before screening;
- Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
- 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);
- TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
- Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
- Those who cannot be treated with oral drugs;
- Allergic to hetrombopag or any excipient;
- 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%).
Sites / Locations
- xianglin YuanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Observation group
Arm Description
Herombopag Olamine Tablets
Outcomes
Primary Outcome Measures
Days required for platelet recovery to ≥75×10^9/ L
Days required for platelet recovery to ≥75×10^9/ L
Secondary Outcome Measures
The lowest platelet count
The lowest platelet count
Safety of treatment
Measure of time from study enrollment until progression.
Full Information
NCT ID
NCT05575986
First Posted
September 25, 2022
Last Updated
October 7, 2022
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05575986
Brief Title
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy
Acronym
hetrombopag
Official Title
An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Tumors of the Digestive System, Trombocitopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation group
Arm Type
Experimental
Arm Description
Herombopag Olamine Tablets
Intervention Type
Drug
Intervention Name(s)
Hetrombopag Olamine
Intervention 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.
Primary Outcome Measure Information:
Title
Days required for platelet recovery to ≥75×10^9/ L
Description
Days required for platelet recovery to ≥75×10^9/ L
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
The lowest platelet count
Description
The lowest platelet count
Time Frame
At the end of Cycle 2 (each cycle is 28 days)
Title
Safety of treatment
Description
Measure of time from study enrollment until progression.
Time Frame
2 Cycle (each cycle is 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteer to participate in clinical research and sign informed consent;
Age ≥18 years;
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;
At least 10 days between TPO, IL-11 or platelet transfusion;
ECOG 0 to 2 points;
Expected survival time > 3 months;
Sufficient organ function for subsequent chemotherapy;
Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.
Exclusion Criteria:
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;
Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
Clinically significant acute or active bleeding within the week prior to screening;
Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
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);
Subjects had a history of arterial or venous thrombosis within 3 months before screening;
Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
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);
TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
Those who cannot be treated with oral drugs;
Allergic to hetrombopag or any excipient;
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%).
Facility Information:
Facility Name
xianglin Yuan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xianglin Yuan, doctor
Phone
13667241722
Email
yuanxianglin@hust.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy
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