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

NCT ID: NCT07268898

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2026-06-30

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.

Conditions

Immune Thrombocytopenia (ITP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Treated Group

No interventions assigned to this group

Untreated Group

No interventions assigned to this group

Eligibility Criteria

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

-

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhang Lei, MD

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

QT2025009

Identifier Type: -

Identifier Source: org_study_id