NCT07268898

National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study is a nationwide, multicenter, retrospective, real-world, non-interventional (observational) investigation. It retrospectively collects data on treatment modalities and therapeutic responses in patients with newly diagnosed or persistent immune thrombocytopenia (ITP), documents disease progression in both treated and untreated patients, and records the treatment regimens selected by those receiving therapy. The study aims to observe and evaluate the current treatment landscape for newly diagnosed and persistent ITP patients, while also analyzing the efficacy and safety in the treated population. All patient treatments and disease management are solely based on routine clinical practice and are not influenced by this study.

Detailed description

Currently, there is a lack of data on the treatment landscape for newly diagnosed and persistent ITP in China. No information is available regarding the proportion of treated and untreated patients, treatment choices, or therapeutic outcomes in this population. This study retrospectively collects data on treatment approaches and response outcomes in patients with newly diagnosed or persistent ITP, documenting disease progression in both treated and untreated individuals, as well as the treatment regimens selected by those receiving therapy. It aims to observe and analyze the current treatment patterns for newly diagnosed and persistent ITP patients in China, with the goal of clarifying the treatment needs for thrombopoietin receptor agonists (TPO-RAs) in this population. Additionally, the efficacy and safety of treatments in the studied cohort will be evaluated. This study is designed to observe and assess the current treatment status of patients with newly diagnosed and persistent ITP.

Conditions

• Immune Thrombocytopenia (ITP)

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-02-25
• Completion: 2026-06-30
• First posted: 2025-12-08
• Last updated: 2025-12-08