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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07268898

Enrollment

500

Registered

2025-12-08

Start date

2025-11-25

Completion date

2026-06-30

Last updated

2025-12-08

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

Conditions

Immune Thrombocytopenia (ITP)

Keywords

RWS

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* Availability of traceable inpatient medical records; Clinically diagnosed with newly diagnosed or persistent ITP (ITP disease course ≤12 months) between July 2021 and September 2025; Baseline platelet count \<30×10⁹/L; Age ≥6 years; Inclusion of patients regardless of ITP treatment status, encompassing those receiving any ITP-directed therapy (excluding emergency treatments such as platelet transfusion) and untreated patients (who have not received ITP-specific treatments including glucocorticoids, intravenous immunoglobulin, TPO-RAs, splenectomy, and rituximab).

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving a platelet count ≥30×10⁹/L within 8 weeks, with at least a twofold increase from baseline, and no bleeding manifestations	2026.2.25

Outcome results