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A multicenter clinical and translational study of three types of thrombopoietin receptor agonists in the treatment of childhood immune thrombocytopenia

A multicenter clinical and translational study of three types of thrombopoietin receptor agonists in the treatment of childhood immune thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095156
Enrollment
Unknown
Registered
2025-01-02
Start date
2024-02-14
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune thrombocytopenia

Interventions

Hetrombopag group:Hetrombopag(Oral)
Avatrombopag group:Avatrombopag(Oral)
Eltrombopag:Eltrombopag(Oral)

Sponsors

Fuyang People's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) The diagnosis meets the criteria for primary immune thrombocytopenia in children in the 2021 version; (2) Aged 1 to 18; (3) Physical strength score meets level 1-3 (WHO standard); (4) Bone marrow cell morphology: megakaryocytes in bone marrow >=50; (5) Children with newly diagnosed ITP must have received standardized first-line treatment that is ineffective or dependent on first-line treatment. (6) After treatment, the platelet count is still = 6 months of persistent ITP or chronic ITP; (7) Family members agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe dysfunction of important organs such as heart, liver, and kidney; (2) other malignant tumors and autoimmune diseases; (3) Children with contraindications to the use of eltrombopag, hetrombopag or avatrombopag; (4) There are various situations that other researchers believe cannot be carried out.

Design outcomes

Primary

MeasureTime frame
Overall response rate after 8 weeks of drug treatment;

Secondary

MeasureTime frame
Proportion of patients with CR and PR after 8 weeks of drug treatment;Maximum duration and total duration of cr/pr after 24 weeks of drug treatment;Proportion of patients with at least one response within 8 weeks of drug treatment;First onset time of drug treatment;Proportion of patients requiring rescue treatment with protocol cancellation;Proportion of patients who responded after 2, 3, 4, 5, 6, 7, and 8 weeks of drug treatment;

Countries

China

Contacts

Public ContactXu Zhang

Fuyang People's hospital

yimiyang6@163.com+86 136 2558 6281

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026