Status:
UNKNOWN
A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Tumor Therapy-related Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia
Detailed Description
CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower t...
Eligibility Criteria
Inclusion
- Age ≥18, no gender limitation;
- Participants with solid tumors confirmed by histopathological or cytological examination;
- During the current tumor treatment cycle, the participants whose PLT\<50×109/L, and will receive the current tumor treatment regimen for at least 1 cycle;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Voluntarily participated in the study and signed the informed consent with good compliance.
Exclusion
- Suffering from any of the following diseases of the hematopoietic system other than thrombocytopenia caused by tumor therapy, including but not limited to leukemia, primary immune thrombocytopenia, myeloid proliferative disease, multiple myeloma and myelodysplastic syndrome;
- Suffering from thrombocytopenia (not caused by tumor treatment), including but not limited to chronic liver disease, hypersplenism, infection, and bleeding, within 6 months prior to screening;
- Bone marrow invasion or bone marrow metastasis;
- Received radiation therapy to the pelvis, spine and bone field within 3 months prior to screening; or is/is expected to receive radiation therapy.
- Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the current cancer treatment cycle;
- Received platelet transfusion within 3 days prior to randomization;
- Participants with known or expected allergy or intolerance to the active ingredient or excipient of Herombopag Olamine tablets;
- Pregnant or lactating women;
- Participants who are participating in other clinical trials.
- Other conditions that the investigator determines are not suitable for inclusion in the study.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05350956
Start Date
June 1 2022
End Date
October 30 2023
Last Update
April 28 2022
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