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A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

NCT05350956 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-28

No results posted yet for this study

Summary

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

Conditions

  • Tumor Therapy-related Thrombocytopenia

Interventions

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.

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.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Zong Hong, Professor · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-06-01
Completion
2023-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350956 on ClinicalTrials.gov