An observational study in Immune Thrombocytopenia, sponsored by Jena University Hospital. Recruiting at 64 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Jena University Hospital · Observational
The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.
Immune thrombocytopenia (ITP) is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets.
In recent years, new treatment options for patients with immune thrombocytopenia have emerged.
The results of published clinical studies on ITP can only be used for broad patient care to a limited extent, as they are designed for a patient population with clearly defined inclusion and exclusion criteria. Real world data collected from this registry will help to better understand the diagnosis and therapy of ITP patients in everyday treatment and to more effectively direct individual patients to optimal therapy, thus improving their outcomes.
By collecting biospecimens, this project will contribute new knowledge to the study of ITP through standardized, systematic, and high-quality collection and storage of patient samples and associated data.
The registry collects clinical data from patients diagnosed with ITP at defined points in the course of the disease. The Data collection includes a range of clinical measures, disease-related factors, treatment/treatment course and outcomes, complications during treatment and Qol, fatigue scoring and survival data (up to 5 years).
The data are collected prospectively. In addition, patients can be included retrospectively up to 12 months after the initial diagnosis if continuous documentation can be provided at the treatment centre. In both cases, a written declaration of consent is obligatory.
517 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 161 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 131 across 108 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Jena University Hospital is the lead sponsor of 62 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Immune thrombocytopenia (ITP) which is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets. There is a distinction between a primary form, in which no triggering cause is identifiable, and secondary forms, which may for example occur in the context of systemic autoimmune diseases or drug-induced.
Exclusion Criteria:
epidemiological data on ITP - Incidence
Incidence: number of reported ITP, estimate incidence by zip code area
Time frame: At enrollment
epidemiological data on ITP - Age
Age (year of birth)
Time frame: At enrollment
epidemiological data on ITP - Sex distribution
Sex distribution: female, male
Time frame: At enrollment
Description of the causes of ITP
causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)
Time frame: At enrollment
ITP treatment type received
Medical therapies received
Time frame: 5 years
Remission
Remission Status
Time frame: 5 years
Recording of clinical characteristics of affected patients - Disease stage
bleeding severity WHO-CTCAE Grade 1-4
Time frame: At enrollment, 6 months, annually up to 5 years
Recording of clinical characteristics of affected patients- platelet counts
platelet counts in Gpt/l
Time frame: At enrollment, 6 months, annually up to 5 years
Recording of clinical characteristics of affected patients -disease manifestation at diagnosis
Localisation of bleeding and severity (WHO-CTCAE Grading)
Time frame: At enrollment
Bleeding events
Bleeding events (yes, no)
Time frame: At enrollment, 6 months, annually up to 5 years
thromboembolic events
thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other)
Time frame: At enrollment, 6 months, annually up to 5 years
Quality of Life questionaire
ILQI questionaire
Time frame: At enrollment, 6 months, annually up to 5 years
fatigue assessment
FACIT-F questionaire: subscale fatigue (only last 13 questions)
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters ANA
ANA (negative/positive)
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters APL-Antibodies
APL-Antibodies (negative/positive)
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters Lupus-Antibodies
lupus-Antibodies (negative/positive)
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters platelet autoantibodies
platelet autoantibodies (negative/positive)
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters helicobacter pylori
helicobacter pylori (negative/positive)
Time frame: At enrollment, 6 months, annually up to 5 years
Plan to share: No — There is no validated data sharing procedure at the university hospital Jena. But of course it is planned to share the results with scientific community and publish the data in a scientific journal.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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