A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

Phase 2

• Conditions: Tumor Therapy-related Thrombocytopenia
• Interventions: Drug: TPO-RA (Herombopag); Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)

• Registration Number: NCT05350956
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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 than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.

Study Timeline

• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-27
• Last Update Submitted: 2022-04-27
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-04-28
• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Herombopag monotherapy	TPO-RA (Herombopag)	-
Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)	TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)	-

Primary Outcome Measures

Name	Time	Method
During the correction period, the percentage of patients whose platelets returned to normal within 14 days	up to 14 days	Percentage of patients whose platelets returned to normal within 14 days

Secondary Outcome Measures

Name	Time	Method
During the correction period, the median time for platelet values to return to normal	up to 60 days	Median time for platelet values to return to normal
During the correction period, the Median time for platelet count to return to 75×109/L	up to 60 days	Median time for platelet count to return to 75×109/L
During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days	up to 14 days	Percentage of patients whose platelets returned to75×109/L within 14 days
During the correction period, platelet infusion rate after initiation of Herombopag therapy.	up to 14 days	During the correction period, platelet infusion rate after initiation of Herombopag therapy.
During the prophylaxis period, the proportion of patients whose PLT<75×109/L	up to 14 days	During the prophylaxis period, the proportion of patients whose PLT\<75×109/L
During the prophylaxis period, the proportion of patients whose PLT<50×109/L	up to 14 days	During the prophylaxis period, the proportion of patients whose PLT\<50×109/L
During the prophylaxis period, platelet counts are at their lowest.	up to 14 days	During the prophylaxis period, platelet counts are at their lowest.
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.	up to 14 days	During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
Platelet value curve	up to 60 days	Platelet value curve
During the correction period, the median time for platelet count to return to 50×109/L	up to 60 days	Median time for platelet count to return to 50×109/L
During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days	up to 14 days	Percentage of patients whose platelets returned to 50×109/L within 14 days