Immune Thrombocytopenia (ITP)NCT07268898
National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients
An observational study of Immune Thrombocytopenia (ITP), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients deemed ineligible for the study based on the investigator's judgment.
Who may be able to join
- 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).
Who cannot join
- -
About this study
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.
Read the 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)
- Keywords
- RWS
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Not described | |
| Untreated Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2026.2.25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start25 Nov 2025 (estimated)
- Primary completion25 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Lei, MD, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268898
- Sponsor's protocol ID
- QT2025009
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients
- ClinicalTrials.gov ID
- NCT07268898
- Acronym / sponsor ID
- QT2025009
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- RWS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Group | – | – |
| Untreated Group | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients deemed ineligible for the study based on the investigator's judgment.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 2026.2.25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia (ITP), run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2026.2.25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.