Immune Thrombocytopenia Clinical Trial
— sic-regOfficial title:
Register für Schwere Immunzytopenien - Severe Immune Cytopenia Registry (SIC-Reg.Org)
Verified date | January 2024 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and Evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments. Time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion. No intervention, mere observation and documentation. Guided pre-inclusion (differential) diagnostic work-up.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 25 Years |
Eligibility | Inclusion Criteria: - Autoimmune hemolytic anemia (AIHA) - Evans syndrome (ES) - Persistent or chronic immune thrombocytopenia (ITP; >6 months after first manifestation) Exclusion Criteria: - (history of) malignancies - (history of) hematopoietic stem cell transplantation |
Country | Name | City | State |
---|---|---|---|
Austria | Pediatric Hematology-Oncology Outpatient Clinic | Graz | Styria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | underlying disease that causes or is associated with severe immune cytopenia | identify the underlying condition or other disease, e.g., primary immunodeficiency or bone marrow failure syndrome by diagnostic procedures according to a standardized algorithm | 0-4 years | |
Secondary | Clinical course | Documentation of physician-reported clinical symptoms including outcome measures/performance scores | 0-4 years | |
Secondary | Biomarkers - Blood | Identification of novel biomarkers by flow cytometry of leukocytes | 0-4 years | |
Secondary | Biomarkers - Stool | Identification of potential modifiers of immune tolerance by studying the intestinal microbiome | 0-4 years | |
Secondary | Routine laboratory parameters | documentation of laboratory parameters that are routinely assessed for immune cytopenia | 0-4 years | |
Secondary | Number of participants with the diagnosis of severe immune cytopenia per participating centre and per year | epidemiological data acquisition, participants included according to the inclusion criteria | 0-4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
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 |
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 |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
Not yet recruiting |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
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 | |
Withdrawn |
NCT01976195 -
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
|
Phase 2 | |
Completed |
NCT01933035 -
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
|
N/A | |
Recruiting |
NCT02821572 -
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
|