Immune ThrombocytopeniaPhase 3NCT05685420
Extension Study of Herombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
A Phase 3 study testing Herombopag in people with Immune Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Herombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2023to 30 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extension Study of Herombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia
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.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Herombopag
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerombopagDrug
Thrombopoietin receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| open-label | Experimental | Herombopag plus standard of care Receives: Drug: Herombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with new myelofibrosis，new cataract, or existing cataract progression during the extended study.
Measured: from baseline to 28 days after the last dose
All AESIs，whether or not associated with study drugs.
Measured: from baseline to 28 days after the last dose
All SAEs，whether or not associated with study drugs.
Measured: from baseline to 28 days after the last dose
All AEs that result in discontinuation of medication.
Measured: from baseline to 28 days after the last dose
All AEs that lead to permanent withdrawal.
Measured: from baseline to 28 days after the last dose
Blood Biochemistry-ALT.
Measured: 6 months
Blood Biochemistry-AST.
Measured: 6 months
Blood Biochemistry-GGT.
Measured: 6 months
Blood Biochemistry-ALP.
Measured: 6 months
Blood Biochemistry-TBIL.
Measured: 6 months
Blood Biochemistry-DBIL.
Measured: 6 months
Blood Biochemistry-creatinine.
Measured: 6 months
Secondary outcomes (4)
Platelet count at each visiting point.
Measured: 6 months
The incidence and severity of bleeding symptoms.
According to the 2021 version go pediatric ITP bleeding Score Scale.
Measured: 6 months
Percentage of subjects receiving emergency treatment for aggravated ITP.
Measured: 6 months
Percentage of subjects with recurrent ITP.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start23 Jan 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label Herombopag plus standard of care
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685420
- Sponsor's protocol ID
- HR-TPO-ITP-III-PED-EXT
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Herombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05685420
- Acronym / sponsor ID
- HR-TPO-ITP-III-PED-EXT
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label Herombopag plus standard of care
| Arm | Type | Receives |
|---|---|---|
| open-label | Experimental | Drug: HerombopagHerombopag plus standard of care |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HerombopagThrombopoietin receptor agonist | Drug | open-label |
Primary outcome
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
All AESIs，whether or not associated with study drugs.
Time frame: from baseline to 28 days after the last dose
All SAEs，whether or not associated with study drugs.
Time frame: from baseline to 28 days after the last dose
All AEs that result in discontinuation of medication.
Time frame: from baseline to 28 days after the last dose
All AEs that lead to permanent withdrawal.
Time frame: from baseline to 28 days after the last dose
Blood Biochemistry-ALT.
Time frame: 6 months
Blood Biochemistry-AST.
Time frame: 6 months
Blood Biochemistry-GGT.
Time frame: 6 months
Blood Biochemistry-ALP.
Time frame: 6 months
Blood Biochemistry-TBIL.
Time frame: 6 months
Blood Biochemistry-DBIL.
Time frame: 6 months
Blood Biochemistry-creatinine.
Time frame: 6 months
4 secondary outcomes
Platelet count at each visiting point.
Time frame: 6 months
The incidence and severity of bleeding symptoms.
Time frame: 6 months
Percentage of subjects receiving emergency treatment for aggravated ITP.
Time frame: 6 months
Percentage of subjects with recurrent ITP.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herombopag in people with Immune Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyi Zhu, M.M (+0518-82342973, zhenyi.zhu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.