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Extension Study of Herombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Herombopag
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who have completed PartB of HR-TPO-ITP-III-PED clinical trial and have achieved platelet response. Subjects who have signed the informed consent for the extended study. Subjects with potential fertility(e.g. women who have menarche or men who have sperm loss) should agree to use effective contraception during their participation in the extended study and within 28 days after their last dose. Subjects who have completed end-of-treatment visits in the original study. Exclusion Criteria: Any unstable condition or condition that may compromise the safety of the subject. Patients with new myelofibrosis were examined in the original clinical trial exit group. The original clinical trial cohort examined evidence of new cataract or existing cataract progression, and the study considered it unsuitable to enroll in this extension. Patients with uncontrolled bleeding after standard treatment. Any previous occurrence of arterial or venous thrombosis (transient ischemic attack,myocardial infarction ,deep venous thrombus, or pulmonary embolism ),or clinical symptoms and history suggest thrombus susceptibility. Any other circumstances that the investigator considers likely to cause the subject to be unable to complete the study or to present a significant risk to the subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    open-label

    Arm Description

    Herombopag plus standard of care

    Outcomes

    Primary Outcome Measures

    Percentage of subjects with new myelofibrosis,new cataract, or existing cataract progression during the extended study.
    All AESIs,whether or not associated with study drugs.
    All SAEs,whether or not associated with study drugs.
    All AEs that result in discontinuation of medication.
    All AEs that lead to permanent withdrawal.
    Blood Biochemistry-ALT.
    Blood Biochemistry-AST.
    Blood Biochemistry-GGT.
    Blood Biochemistry-ALP.
    Blood Biochemistry-TBIL.
    Blood Biochemistry-DBIL.
    Blood Biochemistry-creatinine.

    Secondary Outcome Measures

    Platelet count at each visiting point.
    The incidence and severity of bleeding symptoms.
    According to the 2021 version go pediatric ITP bleeding Score Scale.
    Percentage of subjects receiving emergency treatment for aggravated ITP.
    Percentage of subjects with recurrent ITP.

    Full Information

    First Posted
    January 6, 2023
    Last Updated
    January 13, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05685420
    Brief Title
    Extension Study of Herombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
    Official Title
    Extension Study of Herombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 23, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    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 main purpose of this extended study is to enable subjects who are currently receiving the PartB experimental drug in the HR-TPO-ITP-III-PED clinical trial .To continue receiving the experimental drug after the completion of the clinical trial if they benefit from the treatment at the end of the clinical trial.Until the study physician determines that the subject has failed treatment or that the subject can no longer benefit from treatment or extends the study treatment for 6 months.In addition, the secondary purpose of this extended study was to observe the long-term efficacy and safety of tripodal in children and adolescents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune Thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    open-label Herombopag plus standard of care
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    117 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    open-label
    Arm Type
    Experimental
    Arm Description
    Herombopag plus standard of care
    Intervention Type
    Drug
    Intervention Name(s)
    Herombopag
    Intervention Description
    Thrombopoietin receptor agonist
    Primary Outcome Measure Information:
    Title
    Percentage of subjects with new myelofibrosis,new cataract, or existing cataract progression during the extended study.
    Time Frame
    from baseline to 28 days after the last dose
    Title
    All AESIs,whether or not associated with study drugs.
    Time Frame
    from baseline to 28 days after the last dose
    Title
    All SAEs,whether or not associated with study drugs.
    Time Frame
    from baseline to 28 days after the last dose
    Title
    All AEs that result in discontinuation of medication.
    Time Frame
    from baseline to 28 days after the last dose
    Title
    All AEs that lead to permanent withdrawal.
    Time Frame
    from baseline to 28 days after the last dose
    Title
    Blood Biochemistry-ALT.
    Time Frame
    6 months
    Title
    Blood Biochemistry-AST.
    Time Frame
    6 months
    Title
    Blood Biochemistry-GGT.
    Time Frame
    6 months
    Title
    Blood Biochemistry-ALP.
    Time Frame
    6 months
    Title
    Blood Biochemistry-TBIL.
    Time Frame
    6 months
    Title
    Blood Biochemistry-DBIL.
    Time Frame
    6 months
    Title
    Blood Biochemistry-creatinine.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Platelet count at each visiting point.
    Time Frame
    6 months
    Title
    The incidence and severity of bleeding symptoms.
    Description
    According to the 2021 version go pediatric ITP bleeding Score Scale.
    Time Frame
    6 months
    Title
    Percentage of subjects receiving emergency treatment for aggravated ITP.
    Time Frame
    6 months
    Title
    Percentage of subjects with recurrent ITP.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who have completed PartB of HR-TPO-ITP-III-PED clinical trial and have achieved platelet response. Subjects who have signed the informed consent for the extended study. Subjects with potential fertility(e.g. women who have menarche or men who have sperm loss) should agree to use effective contraception during their participation in the extended study and within 28 days after their last dose. Subjects who have completed end-of-treatment visits in the original study. Exclusion Criteria: Any unstable condition or condition that may compromise the safety of the subject. Patients with new myelofibrosis were examined in the original clinical trial exit group. The original clinical trial cohort examined evidence of new cataract or existing cataract progression, and the study considered it unsuitable to enroll in this extension. Patients with uncontrolled bleeding after standard treatment. Any previous occurrence of arterial or venous thrombosis (transient ischemic attack,myocardial infarction ,deep venous thrombus, or pulmonary embolism ),or clinical symptoms and history suggest thrombus susceptibility. Any other circumstances that the investigator considers likely to cause the subject to be unable to complete the study or to present a significant risk to the subject.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenyi Zhu, M.M
    Phone
    +0518-82342973
    Email
    zhenyi.zhu@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Extension Study of Herombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

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