A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia

The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia

Study Overview

• Status: Not yet recruiting
• Conditions: Tumor Therapy-related Thrombocytopenia
• Intervention / Treatment: Drug: TPO-RA (Herombopag); Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zong Hong, Professor; Phone Number: 13523586882; Email: fcczongh@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Herombopag monotherapy	Drug: TPO-RA (Herombopag); 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.
Experimental: Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)	Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
During the correction period, the median time for platelet values to return to normal	Median time for platelet values to return to normal	up to 60 days
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	up to 60 days
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	up to 60 days
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	up to 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	up to 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.	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<75×109/L	up to 14 days
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	up to 14 days
During the prophylaxis period, platelet counts are at their lowest.	During the prophylaxis period, platelet counts are at their lowest.	up to 14 days
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.	During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.	up to 14 days
Platelet value curve	Platelet value curve	up to 60 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Zong Hong, Professor, The first affiliated hospital of Zhengzhou university

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: HQBP-ZH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No