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Evaluation of the efficacy of the second-line ascending treatment strategy for children with severe chronic immune thrombocytopenia: a multicenter non-inferiority clinical study

Evaluation of the efficacy of the second-line ascending treatment strategy for children with severe chronic immune thrombocytopenia: a multicenter non-inferiority clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048162
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Chronic ITP in children

Interventions

experiment group:second-line ascending treatment strategy

Sponsors

Beijing Children Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. The ITP diagnosis meets the 2019 ICR diagnostic criteria; 2. Aged 1 to 14 years before starting treatment; 3. Chronic ITP: the course of the disease exceeds 12 months; 4. Severe: the number of platelets is less than 30x10^9/L, the combined bleeding (grade 1-3 bleeding) requires treatment or interferes with life, and the parents or children strongly demand treatment; 5. Ineffective first-line treatment: those who have previously used gamma globulin and/or glucocorticoid treatment ineffective; 6. No contraindications to drug treatment; 7. It can ensure long-term follow-up in the diagnosis and treatment center; 8. Obtain the consent of the patient or/and the guardian and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There was life-threatening bleeding at the time of enrollment, and the ICR bleeding score scale was level 4; 2. Any significant abnormal coexisting diseases or mental illnesses, affecting the patient's life safety and compliance, affecting informed consent, research participation, follow-up or results Explanation; 3. The child or guardian cannot be followed up, and the compliance is poor.

Design outcomes

Primary

MeasureTime frame
Response rate;

Secondary

MeasureTime frame
Quality of life improvement rate;Expenses during treatment;

Countries

China

Contacts

Public ContactWu Runhui

Beijing Children Hospital, Capital Medical University

runhuiwu@hotmail.com+86 13911383480

Outcome results

None listed

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