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Clinical Trials in China / NCT07068425
Starting soon Observational

Longitudinal Observational Study on Immune Thrombocytopenia

NCT07068425 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Observational
Started
2025-07-10
Last updated
2025-07-16

Condition(s) studied

Immune Thrombocytopenia (ITP)

Study summary

Immune Thrombocytopenia (ITP) is a bleeding disorder characterized by immune-mediated destruction and/or impaired production of platelets, leading to clinical manifestations such as petechiae, purpura, mucosal bleeding, and in severe cases, life-threatening visceral or intracranial hemorrhage. Research on the diagnosis, treatment, and prognosis of ITP is critical for improving patient outcomes and quality of life. However, most existing hematologic cohort studies are limited to single-center or small multicenter samples, lacking comprehensive, large-scale prospective investigations.

To address this gap, our center plans to conduct a large-sample, combined retrospective and prospective longitudinal observational cohort study of ITP patients. The study will enroll patients to collect baseline demographic and diagnostic data, followed by longitudinal follow-up via questionnaires, telephone interviews, video consultations, online platforms, and in-person visits. Key variables including treatment regimens, comorbidities, and prognostic outcomes will be systematically recorded. Additionally, hospitalization and outpatient expenditure data will be extracted from electronic medical records.

This study aims to provide high-quality real-world evidence on the epidemiology, treatment patterns, clinical outcomes, and healthcare costs of ITP patients in China, ultimately informing clinical decision-making and health policy.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patients with confirmed diagnosis of ITP 2. Patients treated at Peking University People's Hospital since January 1, 2005 Exclusion Criteria: 1. Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders" 2. Patients deemed ineligible for the study by investigators"

Primary outcome measure(s)

  • Prognosis — 5 years
    To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP), and analyze the risk factors associated with their prognosis.
  • Overall response rate — 180 days
    To analyze the therapeutic efficacy of patients with ITP, and analyze the impact factors associated with the efficacy.
  • Long-term overall remission rate — 1 year
    Proportion of the participants with an overall remission.
  • Comorbidities — 5 years
    The incidence, risk factors, treatments, and prognosis of complications

Trial sites (1)

FacilityCityRegionStatus
Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing 100010 Beijing China

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Other trials for the same condition

An Exploratory Study of Golidocitinib in Adult Patients With ITP Starting soon
A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C)in Patients With Refractory Primary Immune Thrombocytopenia Starting soon
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia Recruiting
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2) Recruiting
Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07068425 on ClinicalTrials.gov ↗ ← All trials in China