Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer
Primary Purpose
Tumor Chemotherapy-related Thrombocytopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Herombopag Olamine
Sponsored by
About this trial
This is an interventional treatment trial for Tumor Chemotherapy-related Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- Voluntarily participate in the trial and sign the informed consent form; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle
Exclusion Criteria:
- Screening or baseline platelet value < 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value < 1.0 × 109 / L, hemoglobin < 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.
Sites / Locations
- The second hospital of Shanxi Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
test group
Arm Description
Outcomes
Primary Outcome Measures
Platelet index
Destroy after use
Secondary Outcome Measures
Full Information
NCT ID
NCT05160857
First Posted
December 6, 2021
Last Updated
December 6, 2021
Sponsor
Second Hospital of Shanxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05160857
Brief Title
Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer
Official Title
Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Hospital of Shanxi Medical University
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
This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L; At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Chemotherapy-related Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Herombopag Olamine
Intervention Description
The initial dose of hetropapa is recommended to be 7.5mg, once a day, oral on an empty stomach, and can only be eaten after oral administration for 2 hours, so as to avoid taking it with meals.
Primary Outcome Measure Information:
Title
Platelet index
Description
Destroy after use
Time Frame
Blood routine tests were conducted every three days within 14 days after taking the drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily participate in the trial and sign the informed consent form; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet < 75 × 109/L At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle
Exclusion Criteria:
Screening or baseline platelet value < 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value < 1.0 × 109 / L, hemoglobin < 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.
Facility Information:
Facility Name
The second hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
晋荣 武
Phone
138 3461 6752
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer
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