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NCT05152238 Clinical Trial

ITP Registry and Accompanying Biospecimen Collection

Immune Thrombocytopenia Clinical Trial

— ITP-Registry  

Official title:
Multicenter National ITP Registry and Accompanying Biospecimen Collection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05152238
Other study ID # ZKSJ0142
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 29, 2021
Est. completion date April 2027

Study information
Verified date December 2023
Source Jena University Hospital
Contact Thomas Stauch, Dr. med.
Phone 0049-3641-9326864
Email thomas.stauch@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1100
Est. completion date April 2027
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primary or secondary Immune Thrombocytopenia (ITP) - Age =18 years - signed declaration of consent Exclusion Criteria: - 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitätsklinikum Aachen AöR Aachen
Germany Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie Altenburg
Germany MVZ am Klinikum Aschaffenburg Aschaffenburg
Germany MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus Bad Homburg
Germany Onkologie/Hämatologie Bad Liebenwerda
Germany Onkologie am Segelfliegerdamm Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain Berlin
Germany MVZ Hämatologikum GmbH Biberach
Germany Augusta-Kranken-Anstalt gGmbH Bochum
Germany Klinikum Chemnitz gGmbH Chemnitz
Germany MVZ Klinikum Coburg GmbH Coburg
Germany Klinikum Darmstadt Darmstadt
Germany ARGE e.V. Donauwörth
Germany Gemeinschaftspraxis Hämatologie-Onkologie Dresden
Germany Gemeinschaftspraxis Mohm & Prange-Krex Dresden
Germany Onkozentrum Dresden/Freiberg Dresden
Germany Universitätsklinikum Dresden Dresden
Germany Krankenhaus Düren gGmbH Düren
Germany Onkologische Praxis Erfurt Erfurt
Germany Universitätsklinikum Erlangen Erlangen
Germany Haemostas-Frankfurt Frankfurt am Main
Germany Universitätsklinikum Frankfurt Frankfurt am Main
Germany PIOH Studien und Management GbR Frechen
Germany Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei Garbsen
Germany IOGP Gera MVZ GmbH Gera
Germany ALB FILS Kliniken, Klinik am Eichert Göppingen
Germany Universitätsklinik Greifswald Greifswald
Germany Katholisches Krankenhaus Hagen gGmbH Hagen
Germany Gemeinschaftspraxis, FA für Innere Medizin Halle
Germany MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH Halle
Germany Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH Hamburg
Germany Dres. Kamal & Dorn GbR Hannover
Germany Onkologie am Raschplatz Hannover
Germany Werlhof-Institut MVZ GmbH Hannover
Germany ODZ-Petersen GmbH Heidenheim
Germany St. Bernward Krankenhaus GmbH Hildesheim
Germany Klinikum Idar-Oberstein GmbH Idar-Oberstein
Germany University Hospital Jena Jena
Germany Klinikum Kassel GmbH Kassel
Germany Universitätsklinikum Schleswig-Holstein Kiel
Germany Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin Koblenz
Germany Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung Kronach
Germany MVZ mbH, Onkologische Schwerpunktpraxis Leer
Germany OnkoFor Leipzig GmbH Leipzig
Germany Universitätsklinikum Leipzig Leipzig
Germany Carl-von-Basedow Klinikum Merseburg Merseburg
Germany Gemeinschaftspraxis Hämato-Onkologie München
Germany Dietrich-Bonhoeffer-Klinikum Neubrandenburg Neubrandenburg
Germany MVZ Onko Medical GmbH Neustadt Neustadt Am Rübenberge
Germany Pi.Tri.-Studien GmbH Offenburg
Germany Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa Riesa
Germany Klinikum Südstadt Rostock Rostock
Germany Medcenter Nordsachsen Schkeuditz
Germany Asklepios Klinikum Uckermark Schwedt/Oder
Germany MVZ am Schlossgarten, Zero Praxen Schwetzingen
Germany Onkologiezentrum Soest/Iserlohn Soest
Germany Bundeswehrkrankenhaus Ulm Ulm
Germany Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen
Germany Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH Wolfsburg
Germany Universitätsklinikum Würzburg Würzburg
Germany Praxis für Hämatologie und Internistische Onkologie Zittau

Sponsors (7)
Lead Sponsor Collaborator
Jena University Hospital Amgen, argenx, Grifols Biologicals, LLC, Novartis, Swedish Orphan Biovitrum, University Hospital Dresden

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary epidemiological data on ITP - Incidence Incidence: number of reported ITP, estimate incidence by zip code area At enrollment
Primary epidemiological data on ITP - Age Age (year of birth) At enrollment
Primary epidemiological data on ITP - Sex distribution Sex distribution: female, male At enrollment
Primary Description of the causes of ITP causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others) At enrollment
Primary ITP treatment type received Medical therapies received 5 years
Primary Remission Remission Status 5 years
Secondary Recording of clinical characteristics of affected patients - Disease stage bleeding severity WHO-CTCAE Grade 1-4 At enrollment, 6 months, annually up to 5 years
Secondary Recording of clinical characteristics of affected patients- platelet counts platelet counts in Gpt/l At enrollment, 6 months, annually up to 5 years
Secondary Recording of clinical characteristics of affected patients -disease manifestation at diagnosis Localisation of bleeding and severity (WHO-CTCAE Grading) At enrollment
Secondary Bleeding events Bleeding events (yes, no) At enrollment, 6 months, annually up to 5 years
Secondary thromboembolic events thromboembolic events (no, Deep vein thrombosis, acute pulmonary artery embolism, other) At enrollment, 6 months, annually up to 5 years
Secondary Quality of Life questionaire ILQI questionaire At enrollment, 6 months, annually up to 5 years
Secondary fatigue assessment FACIT-F questionaire: subscale fatigue (only last 13 questions) At enrollment, 6 months, annually up to 5 years
Secondary Laboratory parameters ANA ANA (negative/positive) At enrollment, 6 months, annually up to 5 years
Secondary Laboratory parameters APL-Antibodies APL-Antibodies (negative/positive) At enrollment, 6 months, annually up to 5 years
Secondary Laboratory parameters Lupus-Antibodies lupus-Antibodies (negative/positive) At enrollment, 6 months, annually up to 5 years
Secondary Laboratory parameters platelet autoantibodies platelet autoantibodies (negative/positive) At enrollment, 6 months, annually up to 5 years
Secondary Laboratory parameters helicobacter pylori helicobacter pylori (negative/positive) At enrollment, 6 months, annually up to 5 years
See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)