An observational study in Immune Thrombocytopenia and Myelodysplastic Syndromes, sponsored by Fundacion CRIS de Investigación para Vencer el Cáncer. Completed at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Fundacion CRIS de Investigación para Vencer el Cáncer · Observational
Among 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain — 14 open to participants now, 18 under way, 9 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · Spain.
Among the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain, this one is one of 3 that started in 2018, is one of 6 observational ones, and was the 15th registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →14 of the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain are open now. Recruiting first, the newest first:
TargED Biopharmaceuticals B.V. · Sites in Spain
Ages 18+
CRISPR Therapeutics AG · Sites in Spain, United States, Germany
Ages 18+
Incyte Corporation · Sites in Spain, United States, Australia and 4 more countries
Ages 18+
Sanofi · Sites in Spain, United States, Austria and 7 more countries
Ages 18+
argenx · Sites in Spain, France, Germany and 7 more countries
Ages 12–17
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 18 · Phase 3 23
First in 2006; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is below the median of 122 across 99 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 69 across the 44 interventional studies, 131 across the 6 observational. Of the 31 that completed or were terminated, 21 (68%) have results posted.
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45 of 50 have an industry lead sponsor. The 10 most frequent:
Fundacion CRIS de Investigación para Vencer el Cáncer is the lead sponsor of 7 studies on the registry; none are open to participants now.
Fundacion CRIS de Investigación para Vencer el Cáncer has 1 study filed under Purpura, Thrombocytopenic, Idiopathic — fewer than ten, so there is no comparison to draw.
5 of the studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059000Phase 3Kedrion S.p.A.A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP) | 2026-12 |
| NCT07007962Phase 3SanofiStudy to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment | 2027-11-05 |
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT07043946Climb Bio, Inc.A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP) | 2027-08 |
| NCT07104565Incyte CorporationStudy to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders | 2027-09-23 |
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Among the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Current diagnostic criteria for Immune ThrombocytoPenia (ITP) are mainly based on the presence of low numbers of platelets, excluding other multiple causes of thrombocytopenia, including immunodeficiencies, constitutional or acquired thrombocytopenia, hypersplenism and clonal hematological disorders such as MDS, disorders lymphoproliferative and acute myeloid leukemia (AML), among others. The analysis complementary tests for the diagnosis of ITP include studies basic systematic hematology, together with autoimmune assays and microbiological tests, while the evaluation of bone marrow is limited to elderly patients and/or patients resistant to treatment. Previous research has described the development of Myelodysplastic Syndrome (MDS) in patients with a previous diagnosis of ITP, and even the presence of MDS associated with genetic background. Therefore, it is conceivable fact that a percentage of cases with clinical signs of ITP in the moment of appearance may actually correspond to the first stages of MDS development in which bone marrow cells are not systematically evaluated in the initial presentation.
The anomalous immunophenotypic patterns between multiple compartments of bone marrow cells and peripherally blood (PB) platelets have been characterized through flow cytometry. The flow cytometry currently represents an important complementary tool for diagnosis of MDS that has shown great effectiveness and applicability in the differential diagnosis of non-clonal cytopenias against early MDS and for the detection of stages prior to MDS. Besides, the flow cytometry has made it possible to detect the presence of coexisting features related to MDS in patients with other malignancies hematologic conditions such as multiple myeloma, AML, and lymphocytic leukemia chronic. Therefore, the immunophenotypic analysis of the cells of the bone marrow of patients with ITP at the time of appearance would help to identify the cases that underlie clonal hematopoiesis MDS type. In the present study it is planned a broad characterization immunophenotyping of multiple compartments of bone marrow cells and PB platelets from patients with recently diagnosed ITP and investigate their morphological antecedents, in order to identify those patients who show compatible clonal hematopoietic patterns with MDS evident (or at risk of development), as candidates to receive most appropriate therapeutic methods.
It is estimated that approximately 60 patients will be included in the study, 30 newly diagnosed ITP patients and 30 newly diagnosed MDS cases.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Morphological profile
Bone marrow cell compartment profiles
Time frame: Baseline
Morphological profile
Peripheral blood platelets profiles
Time frame: Baseline
Immunological profile
Bone marrow cell compartment profiles
Time frame: Baseline
Immunological profile
Peripheral blood platelets profiles
Time frame: Baseline
Immunophenotypic abnormalities
Evaluation of abnormal immunophenotypic profiles
Time frame: Baseline
Morphological abnormalities
Evaluation of abnormal morphological profiles.
Time frame: Baseline
Ran from Apr 2018 to primary completion in Apr 2021, 35 months.
Of 31 observational studies under Purpura, Thrombocytopenic, Idiopathic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 35. This study's 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Purpura, Thrombocytopenic, Idiopathic →
Fundacion CRIS de Investigación para Vencer el Cáncer