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

NCT07268898 | Not Yet Recruiting DMC

• 1 other identifier: QT2025009
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia (ITP)

Keywords

RWS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treated Group

Untreated Group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients deemed ineligible for the study based on the investigator's judgment.

You may qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: November 25, 2025
• Primary Completion: February 25, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share