Single-center clinical study of TRAs in the treatment of ITP in Chinese children

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400086099

Enrollment

Unknown

Registered

2024-06-25

Start date

2024-06-27

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

immnue thrombocytopenia

Interventions

observation groupA: explore the efficacy and safty of primary TRAs in the treatment of children's ITP retrospectively :None

observation groupB: explore the efficacy and safty of switch TRAs in the treatment of children's ITP retrospectively :None

Control groupC: adjust the dose of avatrombopag according to the platelet counts:None

Experimental groupC: adjust the dose of avatrombopag according to the serum concertration of avvtromobopag:None

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Part A: ? Aged between 1 to 18 years old; ? meet the Primary immune thrombocytopenia diagnostic criteria; ? Platelet count 100g/L, serum creatinine and bilirubin = 2 times the normal value, AST and ALT= 2 times the normal value. Part B: ? Aged between 1 to 18 years old; ?meet the Primary immune thrombocytopenia diagnostic criteria; ? Platelet count 100g/L, serum creatinine and bilirubin = 2 times the normal value, AST and ALT= 2 times the normal value. Part C: ? Aged between 1 to 18 years old; ? meet the Primary immune thrombocytopenia diagnostic criteria; ? Platelet count 100g/L, serum creatinine and bilirubin = 2 times the normal value, AST and ALT= 2 times the normal value; ? Obtain the consent of the patient's parents and guardians.

Exclusion criteria

Exclusion criteria: ? bone marrow stem cell disease; ? Active malignant tumor; Congenital thrombocytopenia, history of systemic lupus erythematosus, history of Evans syndrome, or other known secondary thrombocytopenia disease version number: Version date: patients with 7 history; A history of venous thrombosis or thrombotic events (myocardial infarction, cerebral infarction, transient ischemic attack, etc.).

Design outcomes

Primary

Measure	Time frame
platelet counts;response rate;	—

Secondary

Measure	Time frame
blooding score;serum concentration of avatrombopag;the reduction rate of avatrombopag;durable response;	—

Countries

China

Contacts

Public ContactXiaoling Cheng,Runhui Wu

Bejing Children's Hospital, Capital Medical University, Beijing, China

chengxiaoling1224@163.com+86 157 2668 5768

Outcome results

None listed

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