Overview

A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

Status:
Not yet recruiting
Trial end date:
2023-10-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Criteria
Inclusion Criteria:

1. Age ≥18, no gender limitation;

2. Participants with solid tumors confirmed by histopathological or cytological
examination;

3. 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;

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

5. Voluntarily participated in the study and signed the informed consent with good
compliance.

Exclusion Criteria:

1. 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;

2. 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;

3. Bone marrow invasion or bone marrow metastasis;

4. Received radiation therapy to the pelvis, spine and bone field within 3 months prior
to screening; or is/is expected to receive radiation therapy.

5. Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the
current cancer treatment cycle;

6. Received platelet transfusion within 3 days prior to randomization;

7. Participants with known or expected allergy or intolerance to the active ingredient or
excipient of Herombopag Olamine tablets;

8. Pregnant or lactating women;

9. Participants who are participating in other clinical trials.

10. Other conditions that the investigator determines are not suitable for inclusion in
the study.