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
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