NCT05685420

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

January 6, 2023

Last Update Submit

January 13, 2023

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (12)

  • Percentage of subjects with new myelofibrosis，new cataract, or existing cataract progression during the extended study.

    from baseline to 28 days after the last dose

  • All AESIs，whether or not associated with study drugs.

    from baseline to 28 days after the last dose

  • All SAEs，whether or not associated with study drugs.

    from baseline to 28 days after the last dose

  • All AEs that result in discontinuation of medication.

    from baseline to 28 days after the last dose

  • All AEs that lead to permanent withdrawal.

    from baseline to 28 days after the last dose

  • Blood Biochemistry-ALT.

    6 months

  • Blood Biochemistry-AST.

    6 months

  • Blood Biochemistry-GGT.

    6 months

  • Blood Biochemistry-ALP.

    6 months

  • Blood Biochemistry-TBIL.

    6 months

  • Blood Biochemistry-DBIL.

    6 months

  • Blood Biochemistry-creatinine.

    6 months

Secondary Outcomes (4)

  • Platelet count at each visiting point.

    6 months

  • The incidence and severity of bleeding symptoms.

    6 months

  • Percentage of subjects receiving emergency treatment for aggravated ITP.

    6 months

  • Percentage of subjects with recurrent ITP.

    6 months

Study Arms (1)

open-label

EXPERIMENTAL

Herombopag plus standard of care

Drug: Herombopag

Interventions

HerombopagDRUG

Thrombopoietin receptor agonist

open-label

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Central Study Contacts

Zhenyi Zhu, M.M

CONTACT

+0518-82342973zhenyi.zhu@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open-label Herombopag plus standard of care
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 17, 2023

Study Start

January 23, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 17, 2023

Record last verified: 2023-01