Immune ThrombocytopeniaITP-RegistryNCT05152238
ITP Registry and Accompanying Biospecimen Collection
An observational study of Immune Thrombocytopenia, run by Jena University Hospital at 64 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- How many people
- 1,100 participants
- Where
- 64 sitesGermany
- Study dates
- 29 Nov 2021to Apr 2027
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Primary or secondary Immune Thrombocytopenia (ITP)
- Age ≥18 years
- signed declaration of consent
Who cannot join
- diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
- no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)
Trial locations and contacts
64 sites in 1 country. Contact the study team or a site near you to ask about taking part.
64 sites in 1 country
Germany64 sites, 64 recruiting
- Recruiting
Universitätsklinikum Aachen AöR
Aachen, 52074
Gerda Silling, Dr
- Recruiting
Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie
Altenburg, 04600
Christina Klötzer, Dr.
- Recruiting
MVZ am Klinikum Aschaffenburg
Aschaffenburg, 63739
Manfred Welslau, Dr.
- Recruiting
MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus
Bad Homburg, 61352
Rosa Sonja Alesci, Dr
- Recruiting
Onkologie/Hämatologie
Bad Liebenwerda, 04924
Stephan Kreher, PD Dr.
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 10117
Marie Luise Hütter-Krönke, Dr.
- Recruiting
Praxis für Hämatologie und Onkologie Berlin-Mitte
Berlin, 10117
Stephan Fuhrmann, Dr.
- Recruiting
Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain
Berlin, 10249
Robert Klamroth, PD Dr.
- Recruiting
Onkologie am Segelfliegerdamm
Berlin, 12487
Jörg Heßling, Dr.
- Recruiting
MVZ Hämatologikum GmbH
Biberach, 88400
Leonid Basovski, Dr.
- Recruiting
Augusta-Kranken-Anstalt gGmbH
Bochum, 44791
Robert Radkowski, Dr.
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Mathias Hänel, PD Dr.
- Recruiting
MVZ Klinikum Coburg GmbH
Coburg, 96450
Christof Lamberti, PD Dr.
- Not yet recruiting
Klinikum Darmstadt
Darmstadt, 64283
- Recruiting
ARGE e.V.
Donauwörth, 86609
Bastian Fleischmann
- Recruiting
Onkozentrum Dresden/Freiberg
Dresden, 01127
Steffen Dörfel
- Recruiting
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307
Thomas Illmer, PD Dr.
- Recruiting
Gemeinschaftspraxis Mohm & Prange-Krex
Dresden, 01307
Johannes Mohm, Dr.
- Recruiting
Universitätsklinikum Dresden
Dresden, 01307
Karolin Trautmann-Grill, Dr.
- Recruiting
Krankenhaus Düren gGmbH
Düren, 52351
Michael Flaßhove, PD Dr.
- Recruiting
Onkologische Praxis Erfurt
Erfurt, 99084
Ulrich Hauch, Dr.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Valeska Brückl, Dr.
- Recruiting
MVZ für Hämatologie und Onkologie Essen
Essen, 45136
Patricia Johansson, PD Dr.
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Jörg Chromik, Dr.
- Recruiting
Haemostas-Frankfurt
Frankfurt am Main, 60596
Wolfgang Mondorf, Dr.
- Recruiting
PIOH Studien und Management GbR
Frechen, 50226
Marcel Reiser, PD Dr.
- Recruiting
Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei
Garbsen, 30823
Petros Panagiotou
- Recruiting
IOGP Gera MVZ GmbH
Gera, 07548
Steffen Gerhardt, Dr.
- Recruiting
ALB FILS Kliniken, Klinik am Eichert
Göppingen, 73035
Johannes Niebling, Dr.
- Recruiting
Universitätsklinik Greifswald
Greifswald, 17475
Thomas Neumann, Dr.
- Recruiting
Katholisches Krankenhaus Hagen gGmbH
Hagen, 58097
Doris Kraemer, Prof. Dr.
- Recruiting
Gemeinschaftspraxis, FA für Innere Medizin
Halle, 06110
Regina Moeller, Dr.
- Recruiting
MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH
Halle, 06110
Timo Behlendorf, Dr.
- Recruiting
Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH
Hamburg, 22767
Julia Wiederhold
- Recruiting
Werlhof-Institut MVZ GmbH
Hanover, 30159
Kai Gutensohn, Prof. Dr.
- Recruiting
Onkologie am Raschplatz
Hanover, 30161
Eyck von der Heyde, Dr.
- Recruiting
Dres. Kamal & Dorn GbR
Hanover, 30625
Haytham Kamal, Dr.
- Recruiting
ODZ-Petersen GmbH
Heidenheim, 89522
Volker Petersen, Dr.
- Recruiting
St. Bernward Krankenhaus GmbH
Hildesheim, 31134
Ulrich Kaiser, Prof. Dr.
- Recruiting
Klinikum Idar-Oberstein GmbH
Idar-Oberstein, 55743
Marina Bischoff, Dr.
- Recruiting
University Hospital Jena
Jena, 07745
Thomas Stauch, MD
- Recruiting
Klinikum Kassel GmbH
Kassel, 34125
Martin Wolf, Prof. Dr.
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Matthias Ritgen, Dr.
- Recruiting
Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
Koblenz, 56073
Jens-Marcus Chemnitz, Dr.
- Recruiting
Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung
Kronach, 96317
Martina Stauch, Dr.
- Recruiting
MVZ mbH, Onkologische Schwerpunktpraxis
Leer, 26789
Lothar Müller, Dr.
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Carmen Herling, Dr.
- Recruiting
OnkoFor Leipzig GmbH
Leipzig, 04289
Andreas Schwarzer, Dr.
- Recruiting
Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie
Magdeburg, 39120
Tobias Ronny Haage, Dr.
- Recruiting
Carl-von-Basedow Klinikum Merseburg
Merseburg, 06217
Susann Schulze, Dr.
- Recruiting
Gemeinschaftspraxis Hämato-Onkologie
München, 81241
Matthias Zingerle, Dr.
- Recruiting
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
Neubrandenburg, 17036
Philipp Hemmati, PD Dr.
- Recruiting
MVZ Onko Medical GmbH Neustadt
Neustadt am Rübenberge, 31535
Munir Rababah, Dr.
- Recruiting
Pi.Tri.-Studien GmbH
Offenburg, 77654
Henning Pelz, Dr.
- Recruiting
Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa
Riesa, 01589
Jörg Schubert, Prof. Dr.
- Recruiting
Klinikum Südstadt Rostock
Rostock, 18059
Beate Krammer-Steiner, Dr.
- Recruiting
Medcenter Nordsachsen
Schkeuditz, 04435
Leanthe Braunert, Dr.
- Recruiting
MVZ am Schlossgarten, Zero Praxen
Schwetzingen, 68723
Christian Kuhn, Dr.
- Recruiting
Onkologiezentrum Soest/Iserlohn
Soest, 59494
Anke Wortmann, Dr.
- Recruiting
Bundeswehrkrankenhaus Ulm
Ulm, 89081
Matthias Müller, Dr.
- Recruiting
Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, 78052
Paul La Rosée, Prof. Dr.
- Recruiting
Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH
Wolfsburg, 38440
Thomas Gabrysiak, Dr.
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Thomas Bumm, Dr.
- Recruiting
Praxis für Hämatologie und Internistische Onkologie
Zittau, 02763
Mathias Schulze, Dr.
About this study
Official title: Multicenter National ITP Registry and Accompanying Biospecimen Collection
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.
Read the detailed description
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.
- Conditions
- Immune Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What is being measured
The primary outcome is the main question the study is designed to answer.
epidemiological data on ITP - Incidence
Incidence: number of reported ITP, estimate incidence by zip code area
Measured: At enrollment
epidemiological data on ITP - Age
Age (year of birth)
Measured: At enrollment
epidemiological data on ITP - Sex distribution
Sex distribution: female, male
Measured: 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)
Measured: At enrollment
ITP treatment type received
Medical therapies received
Measured: 5 years
Remission
Remission Status
Measured: 5 years
Secondary outcomes (12)
Recording of clinical characteristics of affected patients - Disease stage
bleeding severity WHO-CTCAE Grade 1-4
Measured: At enrollment, 6 months, annually up to 5 years
Recording of clinical characteristics of affected patients- platelet counts
platelet counts in Gpt/l
Measured: 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)
Measured: At enrollment
Bleeding events
Bleeding events (yes, no)
Measured: At enrollment, 6 months, annually up to 5 years
thromboembolic events
thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other)
Measured: At enrollment, 6 months, annually up to 5 years
Quality of Life questionaire
ILQI questionaire
Measured: At enrollment, 6 months, annually up to 5 years
fatigue assessment
FACIT-F questionaire: subscale fatigue (only last 13 questions)
Measured: At enrollment, 6 months, annually up to 5 years
Laboratory parameters ANA
ANA (negative/positive)
Measured: At enrollment, 6 months, annually up to 5 years
Laboratory parameters APL-Antibodies
APL-Antibodies (negative/positive)
Measured: At enrollment, 6 months, annually up to 5 years
Laboratory parameters Lupus-Antibodies
lupus-Antibodies (negative/positive)
Measured: At enrollment, 6 months, annually up to 5 years
Laboratory parameters platelet autoantibodies
platelet autoantibodies (negative/positive)
Measured: At enrollment, 6 months, annually up to 5 years
Laboratory parameters helicobacter pylori
helicobacter pylori (negative/positive)
Measured: At enrollment, 6 months, annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start29 Nov 2021
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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
- Prospective
- Enrolment
- 1,100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dresden, Novartis, Swedish Orphan Biovitrum, Grifols Biologicals, LLC, Amgen, argenx
- Responsible party
- Principal investigator, Thomas Stauch, Jena University Hospital
- Investigators
- Thomas Stauch, Dr. med., Study director, Jena University HospitalKarolin Trautmann-Grill, Dr. med., Study director, Dresden Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152238
- Sponsor's protocol ID
- ZKSJ0142
- Acronym
- ITP-Registry
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2021
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter National ITP Registry and Accompanying Biospecimen Collection
- ClinicalTrials.gov ID
- NCT05152238
- Acronym / sponsor ID
- ITP-Registry / ZKSJ0142
- Conditions
- Immune Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Dresden, Novartis, Swedish Orphan Biovitrum, Grifols Biologicals, LLC, Amgen, argenx
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Dec 2021 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Primary or secondary Immune Thrombocytopenia (ITP)
- Age ≥18 years
- signed declaration of consent
Key exclusion criteria (2 listed)
- diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
- no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)
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
epidemiological data on ITP - Incidence
Time frame: At enrollment
Incidence: number of reported ITP, estimate incidence by zip code area
epidemiological data on ITP - Age
Time frame: At enrollment
Age (year of birth)
epidemiological data on ITP - Sex distribution
Time frame: At enrollment
Sex distribution: female, male
Description of the causes of ITP
Time frame: At enrollment
causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)
ITP treatment type received
Time frame: 5 years
Medical therapies received
Remission
Time frame: 5 years
Remission Status
12 secondary outcomes
Recording of clinical characteristics of affected patients - Disease stage
Time frame: At enrollment, 6 months, annually up to 5 years
Recording of clinical characteristics of affected patients- platelet counts
Time frame: At enrollment, 6 months, annually up to 5 years
Recording of clinical characteristics of affected patients -disease manifestation at diagnosis
Time frame: At enrollment
Bleeding events
Time frame: At enrollment, 6 months, annually up to 5 years
thromboembolic events
Time frame: At enrollment, 6 months, annually up to 5 years
Quality of Life questionaire
Time frame: At enrollment, 6 months, annually up to 5 years
fatigue assessment
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters ANA
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters APL-Antibodies
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters Lupus-Antibodies
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters platelet autoantibodies
Time frame: At enrollment, 6 months, annually up to 5 years
Laboratory parameters helicobacter pylori
Time frame: At enrollment, 6 months, annually up to 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 15 Jul 2025.
- Individual participant dataSharing planned: 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.
Related trials for Immune Thrombocytopenia
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
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.
Thomas Stauch, Dr. med. study director
Jena University Hospital
Karolin Trautmann-Grill, Dr. med. study director
Dresden Univeristy Hospital
64 sites 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, run by Jena University Hospital at 64 sites in Germany.
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 3 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: looking for participants now, as of the sponsor's last update on 15 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 64 sites in Germany. 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 Thomas Stauch, Dr. med. (0049-3641-9326864, thomas.stauch@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiological data on ITP - Incidence (time frame: At enrollment). The study lists 6 primary outcomes in all. 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 15 Jul 2025.