Immune Thrombocytopenia (ITP)NCT07068425
Longitudinal Observational Study on Immune Thrombocytopenia
An observational study of Immune Thrombocytopenia (ITP), run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 31 Dec 2036
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with confirmed immune thrombocytopenia (ITP). Diagnostic Criteria for ITP: 1. Sustained platelet count <100×10⁹/L 2. Normal or increased megakaryocyte count in bone marrow with maturation defects 3. Exclusion of other potential causes of thrombocytopenia including: pseudothrombocytopenia, drug-induced thrombocytopenia, viral infections, helicobacter pylori infection, hematologic disorders, autoimmune diseases, hypersplenism, malignancies
Who may be able to join
- Patients with confirmed diagnosis of ITP
- Patients treated at Peking University People's Hospital since January 1, 2005
Who cannot join
- Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders"
- Patients deemed ineligible for the study by investigators"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing 100010
Beijing
About this study
Official title: Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia
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.
Read the detailed description
Immune Thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia with normal or increased megakaryocytes in the bone marrow accompanied by maturation defects. Epidemiological studies estimate its incidence at approximately 2-5 cases per 100,000 individuals in the general population.
The primary clinical manifestation of ITP is bleeding, ranging from minor cutaneous/mucosal hemorrhage to life-threatening organ bleeding. Notably, some patients also exhibit increased risk of thrombotic/embolic events. Embolic complications in critical organs (e.g., heart, brain) may significantly impair quality of life and lead to life-threatening conditions.
Currently, most ITP cohort studies in China are limited to single-center designs or small multicenter studies with insufficient sample sizes. There remains a notable lack of large-scale, longitudinal prospective cohort studies.
To address these limitations, this multicenter, retrospective-prospective longitudinal observational study will enroll diagnosed ITP patients to systematically collect:
Baseline demographic and diagnostic data Prospective follow-up data via questionnaires, telemedicine, and clinical visits Treatment regimens, comorbidities, and prognostic outcomes Healthcare utilization costs through electronic medical records
By establishing this comprehensive real-world database, the study aims to:
Elucidate the epidemiology, treatment patterns, and economic burden of ITP in China Provide evidence-based support for developing novel clinical strategies Improve long-term hemorrhage-free survival rates This investigation will serve as a foundational platform for optimizing ITP management and enhancing patient outcomes across China.
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- Immune Thrombocytopenia
- 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 |
|---|---|---|
| Retrospective cohort | Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. | |
| Prospective cohort | Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. | |
| Retrospective/Prospective cohort | Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis
To analyze the long-term prognosis of patients with immune thrombocytopenia (ITP), and analyze the risk factors associated with their prognosis.
Measured: 5 years
Overall response rate
To analyze the therapeutic efficacy of patients with ITP, and analyze the impact factors associated with the efficacy.
Measured: 180 days
Long-term overall remission rate
Proportion of the participants with an overall remission.
Measured: 1 year
Comorbidities
The incidence, risk factors, treatments, and prognosis of complications
Measured: 5 years
Secondary outcomes (3)
Incidence
To describe the incidence of ITP, and analyze the risk factors associated with these diseases.
Measured: 5 years
Safety of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 1 year
Health economic evaluation
To perform hospital stay and hospitalization cost evaluation in patients with thrombosis and hemostasis diseases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Wuhan TongJi Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, MD, Principal investigator, Peking University Institute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068425
- Sponsor's protocol ID
- PKU-ITP2025
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, An Z, Zhao P, Huang Q, Wu J, He Y, Zhu X, Fu H, Zhang Y, Kong Y, Jiang Q, Jiang H, Lu J, Chang Y, Xu L, Zhao X, Huang X, Zhang X. Unmasking the link: pulmonary embolism risk and outcomes in adults with immune thrombocytopenia. J Thromb Haemost. 2026 May 9:S1538-7836(26)00281-3. doi: 10.1016/j.jtha.2026.04.030. Online ahead of print.
PubMed 42114623
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Longitudinal Observational Study on Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07068425
- Acronym / sponsor ID
- PKU-ITP2025
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- Immune Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Wuhan TongJi Hospital
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 16 Jul 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.
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.
Detailed description
Immune Thrombocytopenia (ITP) is an immune-mediated acquired bleeding disorder characterized by thrombocytopenia with normal or increased megakaryocytes in the bone marrow accompanied by maturation defects. Epidemiological studies estimate its incidence at approximately 2-5 cases per 100,000 individuals in the general population.
The primary clinical manifestation of ITP is bleeding, ranging from minor cutaneous/mucosal hemorrhage to life-threatening organ bleeding. Notably, some patients also exhibit increased risk of thrombotic/embolic events. Embolic complications in critical organs (e.g., heart, brain) may significantly impair quality of life and lead to life-threatening conditions.
Currently, most ITP cohort studies in China are limited to single-center designs or small multicenter studies with insufficient sample sizes. There remains a notable lack of large-scale, longitudinal prospective cohort studies.
To address these limitations, this multicenter, retrospective-prospective longitudinal observational study will enroll diagnosed ITP patients to systematically collect:
Baseline demographic and diagnostic data Prospective follow-up data via questionnaires, telemedicine, and clinical visits Treatment regimens, comorbidities, and prognostic outcomes Healthcare utilization costs through electronic medical records
By establishing this comprehensive real-world database, the study aims to:
Elucidate the epidemiology, treatment patterns, and economic burden of ITP in China Provide evidence-based support for developing novel clinical strategies Improve long-term hemorrhage-free survival rates This investigation will serve as a foundational platform for optimizing ITP management and enhancing patient outcomes across China.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort. |
| Prospective cohort | – | –Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort. |
| Retrospective/Prospective cohort | – | –Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed immune thrombocytopenia (ITP). Diagnostic Criteria for ITP: 1. Sustained platelet count <100×10⁹/L 2. Normal or increased megakaryocyte count in bone marrow with maturation defects 3. Exclusion of other potential causes of thrombocytopenia including: pseudothrombocytopenia, drug-induced thrombocytopenia, viral infections, helicobacter pylori infection, hematologic disorders, autoimmune diseases, hypersplenism, malignancies
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of ITP
- Patients treated at Peking University People's Hospital since January 1, 2005
Key exclusion criteria (2 listed)
- Any condition that may render follow-up data unreliable, including but not limited to severe psychiatric disorders"
- Patients deemed ineligible for the study by investigators"
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
Prognosis
Time frame: 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
Time frame: 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
Time frame: 1 year
Proportion of the participants with an overall remission.
Comorbidities
Time frame: 5 years
The incidence, risk factors, treatments, and prognosis of complications
3 secondary outcomes
Incidence
Time frame: 5 years
Safety of treatment
Time frame: 1 year
Health economic evaluation
Time frame: 5 years
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 16 Jul 2025.
- Derived from this study: PubMed 42114623Zhang L, An Z, Zhao P, Huang Q, Wu J, He Y, Zhu X, Fu H, Zhang Y, Kong Y, Jiang Q, Jiang H, Lu J, Chang Y, Xu L, Zhao X, Huang X, Zhang X. Unmasking the link: pulmonary embolism risk and outcomes in adults with immune thrombocytopenia. J Thromb Haemost. 2026 May 9:S1538-7836(26)00281-3. doi: 10.1016/j.jtha.2026.04.030. Online ahead of print.
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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.
Xiao-Hui Zhang, MD principal investigator
Peking University Institute of Hematology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia (ITP), run by Peking University People's Hospital at 1 site in 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 2 inclusion and 2 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jin Wu, MD (086-01088326002, wujin1996@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07068425, which also lists 1 linked publication.
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 16 Jul 2025.