Back to resultsA Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
Primary Purpose
Tumor Therapy-related Thrombocytopenia
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TPO-RA (Herombopag)
TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)
Sponsored by
About this trial
This is an interventional treatment trial for Tumor Therapy-related Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Herombopag monotherapy
Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)
Arm Description
Outcomes
Primary Outcome Measures
During the correction period, the percentage of patients whose platelets returned to normal within 14 days
Percentage of patients whose platelets returned to normal within 14 days
Secondary Outcome Measures
During the correction period, the median time for platelet values to return to normal
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
Median time for platelet count to return to 75×109/L
During the correction period, the median time for platelet count to return to 50×109/L
Median time for platelet count to return to 50×109/L
During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days
Percentage of patients whose platelets returned to75×109/L within 14 days
During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days
Percentage of patients whose platelets returned to 50×109/L within 14 days
During the correction period, platelet infusion rate after initiation of Herombopag therapy.
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
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
During the prophylaxis period, the proportion of patients whose PLT<50×109/L
During the prophylaxis period, platelet counts are at their lowest.
During the prophylaxis period, platelet counts are at their lowest.
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
Platelet value curve
Platelet value curve
Full Information
NCT ID
NCT05350956
First Posted
March 29, 2022
Last Updated
April 27, 2022
Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05350956
Brief Title
A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
Official Title
A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Therapy-related Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Herombopag monotherapy
Arm Type
Experimental
Arm Title
Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TPO-RA (Herombopag)
Intervention Description
During the correction period, subjects will receive a dose of Herombopag starting at 5-7.5mg once daily, orally for 14 days, subject to dosing adjustment (or discontinuation) depending on their platelet response or at the investigator's discretion. In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.
Intervention Type
Drug
Intervention Name(s)
TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)
Intervention Description
During the correction period, subjects will receive a combination of Herombopag and rhTPO, Herombopag starting at a recommended dose of 5mg once daily for 14 days. The recombinant human thrombopoietin dose is 300U/kg. bw/day or 15000U/day per person, once daily, for 14 consecutive days (or as determined by the investigator). In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.
Primary Outcome Measure Information:
Title
During the correction period, the percentage of patients whose platelets returned to normal within 14 days
Description
Percentage of patients whose platelets returned to normal within 14 days
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
During the correction period, the median time for platelet values to return to normal
Description
Median time for platelet values to return to normal
Time Frame
up to 60 days
Title
During the correction period, the Median time for platelet count to return to 75×109/L
Description
Median time for platelet count to return to 75×109/L
Time Frame
up to 60 days
Title
During the correction period, the median time for platelet count to return to 50×109/L
Description
Median time for platelet count to return to 50×109/L
Time Frame
up to 60 days
Title
During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days
Description
Percentage of patients whose platelets returned to75×109/L within 14 days
Time Frame
up to 14 days
Title
During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days
Description
Percentage of patients whose platelets returned to 50×109/L within 14 days
Time Frame
up to 14 days
Title
During the correction period, platelet infusion rate after initiation of Herombopag therapy.
Description
During the correction period, platelet infusion rate after initiation of Herombopag therapy.
Time Frame
up to 14 days
Title
During the prophylaxis period, the proportion of patients whose PLT<75×109/L
Description
During the prophylaxis period, the proportion of patients whose PLT<75×109/L
Time Frame
up to 14 days
Title
During the prophylaxis period, the proportion of patients whose PLT<50×109/L
Description
During the prophylaxis period, the proportion of patients whose PLT<50×109/L
Time Frame
up to 14 days
Title
During the prophylaxis period, platelet counts are at their lowest.
Description
During the prophylaxis period, platelet counts are at their lowest.
Time Frame
up to 14 days
Title
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
Description
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
Time Frame
up to 14 days
Title
Platelet value curve
Description
Platelet value curve
Time Frame
up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zong Hong, Professor
Phone
13523586882
Email
fcczongh@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zong Hong, Professor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
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