- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160857
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
December 6, 2021 updated by: Wu jin rong, Second Hospital of Shanxi Medical University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030000
- The Second Hospital of Shanxi Medical University
-
Contact:
- 晋荣 武
- Phone Number: 138 3461 6752
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: test group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet index
Time Frame: Blood routine tests were conducted every three days within 14 days after taking the drug
|
Destroy after use
|
Blood routine tests were conducted every three days within 14 days after taking the drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 31, 2021
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2023
Study Registration Dates
First Submitted
December 6, 2021
First Submitted That Met QC Criteria
December 6, 2021
First Posted (ACTUAL)
December 16, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SecondShanxiMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tumor Chemotherapy-related Thrombocytopenia
-
Napolitano MariasantaRegione SiciliaTerminatedThrombocytopenia | Primary Thrombocytopenia,Unspecified | Thrombocytopenia Chemotherapy InducedItaly
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingChemotherapy-Induced Thrombocytopenia
-
Sobi, Inc.CompletedChemotherapy-induced ThrombocytopeniaUnited States, China, Hungary, Poland, Russian Federation, Serbia, Ukraine
-
Beijing Northland Biotech. Co., Ltd.CompletedChemotherapy-induced ThrombocytopeniaChina
-
BioMAS LtdTerminatedChemotherapy Induced ThrombocytopeniaIsrael
-
The First Affiliated Hospital of Zhengzhou UniversityJiangsu HengRui Medicine Co., Ltd.Not yet recruitingTumor Therapy-related Thrombocytopenia
-
Qilu Pharmaceutical Co., Ltd.RecruitingChemotherapy-induced ThrombocytopeniaChina
-
Qilu Pharmaceutical Co., Ltd.CompletedChemotherapy-induced ThrombocytopeniaChina
-
Jiangsu HengRui Medicine Co., Ltd.Withdrawn
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruitingChemotherapy-Induced ThrombocytopeniaChina
Clinical Trials on Herombopag Olamine
-
Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdult Patients With Chronic Primary ITP | Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
-
Hebei Medical University Fourth HospitalNot yet recruiting
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdult Patients With Chronic Primary ITP | Adult Patients With SAA Who do Not Respond Well to Immunosuppressive TherapyChina
-
Peking Union Medical College HospitalNot yet recruiting
-
The First Affiliated Hospital of Zhengzhou UniversityJiangsu HengRui Medicine Co., Ltd.Not yet recruitingTumor Therapy-related Thrombocytopenia
-
Yin JieRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingImmune Thrombocytopenia
-
SuxiaLuoRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.UnknownPurpura, Thrombocytopenic, IdiopathicChina