Portal de investigación
- Inicio
- Proyectos y Estudios
- ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, CON DOBLE ENMASCARAMIENTO, CONTROLADO CON PLACEBO EN PACIENTES CON PÚRPURA TROMBOCITOPÉNICA TROMBÓTICA ADQUIRIDA (PTTA) PARA EVALUAR LA FARMACOCINÉTICA, LA SEGURIDAD Y LA EFICACIA DE RADAMTS-13 (SHP655) AD MINISTRADO JUNTO CON EL TRATAMIENTO DE LA PRÁCTICA CLÍNICA HABITUAL.
ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, CON DOBLE ENMASCARAMIENTO, CONTROLADO CON PLACEBO EN PACIENTES CON PÚRPURA TROMBOCITOPÉNICA TROMBÓTICA ADQUIRIDA (PTTA) PARA EVALUAR LA FARMACOCINÉTICA, LA SEGURIDAD Y LA EFICACIA DE RADAMTS-13 (SHP655) AD MINISTRADO JUNTO CON EL TRATAMIENTO DE LA PRÁCTICA CLÍNICA HABITUAL.
Datos básicos
- Código:
- SHP655-201
- Protocolo:
- SHP655-201
- EUDRACT:
- 2018-003775-35
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2019
- Año de finalización:
- 2022
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
A case of megaloblastic anemia simulating a cold autoimmune hemolytic anemia.
De La Puerta R; (...); Solves P
Article. 2020
A decade of changes in management of immune thrombocytopenia, with special focus on elderly patients.
Lozano ML; (...); Vicente V
Article. 10.1016/j.bcmd.2020.102505. 2021
A randomized phase II study comparing consolidation with a single dose of Y-90 ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results
Lopez-Guillermo, Armando; (...); Tomas, Jose Francisco
Article. 10.1080/10428194.2021.1971216. 2021
A Single-Run Next-Generation Sequencing (NGS) Assay for the Simultaneous Detection of Both Gene Mutations and Large Chromosomal Abnormalities in Patients with Myelodysplastic Syndromes (MDS) and Related Myeloid Neoplasms
Liquori, A; (...); Cervera, J
Article. 10.3390/cancers13081947. 2021
Acute and sustained endothelial damage in COVID-19
Mendez, Raul; (...); Menendez, Rosario
Meeting Abstract. 10.1183/13993003.congress-2021.OA3966. 2021
Acute and sustained increase in endothelial biomarkers in COVID-19.
Méndez R; (...); Menéndez R
Article. 10.1136/thoraxjnl-2020-216797. 2021
Acute hemolytic reaction by anti-Wra: Case report and review of the hemovigilance database of a tertiary care hospital.
Solves, Pilar; (...); de la Rubia, Javier
Article. 10.1016/j.transci.2021.103342. 2022
Addition of chemotherapy to nivolumab after PD-1 inhibitor failure as bridge to allogeneic stem cell transplantation in classical Hodgkin's lymphoma: report on three cases and literature review
Review. 10.1177/20406207211038181. 2021
Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice
Stadtmauer, Edward A.; (...); ZOE-SCT Study Grp Collaborators
Article. 10.1080/21645515.2021.1953346. 2021
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PlumX Metrics
- Citations
- Citation Indexes: 24
- Policy Citations: 3
- Captures
- Readers: 59
- Mentions
- News Mentions: 1
Adoptive transfer of ex-vivo expanded SARS-CoV-2-specific Cytotoxic Lymphocytes: a viable strategy for COVID-19 immunosuppressed patients?
Guerreiro M; (...); Piñana JL
Article. 10.1111/tid.13602. 2021
Allogeneic hematopoietic stem cell transplant recipients in Spain: Human leukocyte antigen characteristics and diversity by high-resolution analysis.
Guerreiro, Manuel; (...); Grupo Español de Trasplante Hematopoyético y Terapia Celular (GETH)
Article. 10.1111/tan.14179. 2021
Analysis of SNP Array Abnormalities in Patients with DE NOVO Acute Myeloid Leukemia with Normal Karyotype
Ibanez, M; (...); Cervera, J
Article. 10.1038/s41598-020-61589-9. 2020
ANALYSIS OF THE CLINICAL EVOLUTION OF PATIENTS WHO UNDERWENT A SECOND AUTOTRANSPLANTATION OF PERIPHERAL BLOOD FOR RELAPSED MULTIPLE MYELOMA
Garcia, Ruiz Raquel; (...); Arnao, Herraiz Mario
Meeting Abstract. 2020
Anti-CD20 monoclonal antibodies in primary progressive multiple sclerosis: a real-life comparative study of rituximab vs. ocrelizumab
Alcala, C.; (...); Casanova, B.
Meeting Abstract. 2021
Best practices and recommendations for drug regimens and plasma exchange for immune thrombotic thrombocytopenic purpura
Gomez-Segui, I, Izquierdo, CP, Comos, JD
Review. 10.1080/17474086.2021.1956898. 2021
Bone marrow derived stem cells restore ovarian function and fertility in premature ovarian insufficiency women. Interim report of a randomized trial: mobilization versus ovarian injection
De Castellvi, NP; (...); Pellicer, A.
Meeting Abstract. 2020
Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplantation in multiple myeloma.
Rosiñol L; (...); Bladé J
Article. 10.1182/blood.2019000241. 2019
Central Nervous System Involvement in Epstein-Barr Virus-Related Post-Transplant Lymphoproliferative Disorders after Allogeneic Hematopoietic Stem Cell Transplantation.
Balaguer-Rosello, Aitana; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2020.12.019. 2021
Cerebral calcium embolism.
Asensi Canto, Pedro; (...); Bonanad Boix, Santiago
Article. 10.1002/ccr3.4962. 2022
Clinical Characteristics and Transfusion Management of Patients Diagnosed of Multiple Myeloma Receiving Daratumumab: Experience of a Single Centre
Arnao, M; (...); Sanz, G
Meeting Abstract. 10.1016/j.clml.2019.09.254. 2019
CLINICAL RESULTS AND TRANSFUSIONAL MANAGEMENT IN PATIENTS WITH MULTIPLE MYELOMA IN TREATMENT WITH DARATUMUMAB: EXPERIENCE OF A SINGLE CENTER
Blanco, J. A.; (...); Sanz Santillana, G.
Meeting Abstract. 2019
COMPARISON BETWEEN INTERMITTENT AND CONTINUOUS HAEMATOPOIETIC PROGENITOR COLLECTION OF THE SPECTRA OPTIA APHERESIS SYSTEM IN A SINGLE CENTRE
De la Puerta Paula, R.; (...); Gomez Segui, I
Meeting Abstract. 2019
Comparison of transfusion requirements in adult patients undergoing Haploidentical or single-unit umbilical cord blood stem cell transplantation
Article. 10.1111/ejh.13270. 2019
COST MINIMIZATION ANALYSIS OF RITUXIMAB BIOSIMILAR VERSUS REFERENCE RITUXIMAB IN THE TREATMENT OF FOLLICULAR LYMPHOMA
Gironella, M.; (...); Oyaguez, I
Meeting Abstract. 2019
Cryopreservation of Allogeneic Hematopoietic Progenitor Cells in The Current SARS-Cov-2 Pandemic: Experience of A Single Centre
Moreno, D; (...); Carpio, N
Meeting Abstract. 2021
CHARACTERIZATION OF CONGENITAL THROMBOTIC THROMBOCYTOPENIC PURPURA BY MEANS OF IMMUNOLOGICAL AND MOLECULAR TECHNIQUES: RESULTS OF THE GEPTT NATIONAL COLLECTION
Liquori, A.; (...); Gomez-Segui, I
Meeting Abstract. 2019
CHRONOLOGICAL AGE AS A PROGNOSTIC FACTOR IN PATIENTS WITH MULTIPLE MYELOMA NEW DIAGNOSIS NOT CANDIDATED FOR TRANSPLANTATION
Martinez Elena, Meseguer; (...); Comos Javier, De la Rubia
Meeting Abstract. 2021
Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia (vol 11, 16867, 2021)
Lozano, Maria L.; (...); Vicente, Vicente
Article. 10.1038/s41598-021-95732-x. 2021
Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia.
Lozano ML; (...); Vicente V
Article. 10.1038/s41598-019-53209-y. 2019
DETERMINATION OF THE CHALLENGES AND OPPORTUNITIES ASSOCIATED WITH PLATELET TRANSFUSION IN THE MANAGEMENT OF PATIENTS WITH SEVERE THROMBOCYTOPENIA ASSOCIATED WITH CHRONIC LIVER DISEASE
Jarque, Ramos, I; (...); Shepherd, Moreno J.
Meeting Abstract. 2020
DETERMINING THE EPIDEMIOLOGY, PATIENT FLOW, TREATMENT AND UNMET NEEDS OF PATIENTS WITH CHRONIC LIVER DISEASE-ASSOCIATED SEVERE THROMBOCYTOPENIA UNDERGOING INVASIVE PROCEDURES IN SPAIN
Andrade, R.; (...); Shepherd, J.
Meeting Abstract. 2019
DEVELOPMENT AND VALIDATION OF A MCDA FRAMEWORK FOR EVALUATION AND DECISION-MAKING OF ORPHAN DRUGS IN SPAIN
Poveda, J. L.; (...); Vitoria, I
Meeting Abstract. 2019
Development and validation of an MCDA framework for evaluation and decision-making of orphan drugs in Spain
Badia, X; (...); Poved, JL
Article. 10.1080/21678707.2019.1652163. 2019
Do Guidelines Influence Diagnostic and Therapeutic Practice in Immune Thrombocytopenia? Results of a Multicenter Retrospective Study
Luisa Lozano, Maria; (...); Vicente Garcia, Vicente
Meeting Abstract. 10.1182/blood-2019-125557. 2019
Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment
Palanques-Pastor T; (...); Poveda Andrés JL
Article. 10.1159/000517813. 2021
Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia.
Peffault de Latour R; (...); Risitano AM
Article. 10.1056/NEJMoa2109965. 2022
ELTROMBOPAG ADDED TO STANDARD IMMUNOSUPPRESSION IMPROVES RESPONSE RATE IN SEVERE APLASTIC ANEMIA: RESULTS OF THE MULTICENTER PHASE III PROSPECTIVE RANDOMIZED RACE TRIAL
Risitano, A. M.; (...); de latour, R. Peffault
Meeting Abstract. 2021
Ex vivo T-cell depletion vs post-transplant cyclophosphamide, sirolimus, and mycophenolate mofetil as graft-vs-host disease prophylaxis for allogeneic hematopoietic stem cell transplantation.
Montoro, Juan; (...); Sanz, Jaime
Article. 10.1111/ejh.13529. 2021
EXPERIENCE IN THE DONATION OF HEMATOPOYETIC PROGENITORS (PH) OF PERIPHERAL BLOOD OF MINOR DONORS
Dominguez Hernandez, L.; (...); Gomez Segui, I
Meeting Abstract. 2019
Extracorporeal photopheresis vs standard therapies for steroid-refractory chronic graft-vs-host disease: Pharmacoeconomic assessment of hospital resource use in Spain.
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.1002/jca.21901. 2021
Genome-wide association study identifies susceptibility loci for acute myeloid leukemia (vol 13, 2, 2022)
Lin, Wei-Yu; (...); Allan, James M.
Article. 10.1038/s41467-021-27679-6. 2022
Genome-wide association study identifies susceptibility loci for acute myeloid leukemia.
Lin WY; (...); Allan JM
Article. 10.1038/s41467-021-26551-x. 2021
GUIDELINES OF PRESCRIPTION IN FIRST LINE OF PATIENTS WITH MULTIPLE MYELOMA NOT CANDIDATES TO TRANSPLANTATION STRATIFIED BY AGE IN REAL LIFE IN SPAIN BETWEEN 2012 AND 2016
Cejalvo, M. J.; (...); Sarra, J.
Meeting Abstract. 2019
High prognostic value of measurable residual disease detection by flow cytometry in chronic lymphocytic leukemia patients treated with front-line fludarabine, cyclophosphamide, and rituximab, followed by three years of rituximab maintenance
Garcia-Marco, JA; (...); GELLC Study Grp
Article. 10.3324/haematol.2018.204891. 2019
IMPACT OF THE TREATMENT OF THE PURE APLASIA OF THE RED SERIES; EXPERIENCE IN A CENTER
Marco, Ayala Javier; (...); Solves, Alcaina Pilar
Meeting Abstract. 2020
Incidence and Management of Aplastic Anemia in Spain (IMAS). An Ambispective Study of Biodonostia / Pethema
Vallejo, C; (...); Jarque, I
Meeting Abstract. 2020
Incidence and outcome of invasive fungal disease after front-line intensive chemotherapy in patients with acute myeloid leukemia: impact of antifungal prophylaxis.
Rodríguez-Veiga R; (...); Sanz GF
Article. 10.1007/s00277-019-03744-5. 2019
Incidence, Diagnosis, and Outcome of Acquired Thrombotic Thrombocytopenic Purpura (aTTP): A Nationwide Survey By the Spanish Apheresis Group
Izquierdo, Maria Cristina Pascual; (...); Salinas, Ramon
Meeting Abstract. 10.1182/blood-2019-123258. 2019
Incidence, diagnosis, and outcome of immune-mediated thrombotic thrombocytopenic purpura: A nationwide survey by the Spanish registry of thrombotic thrombocytopenic purpura
Pascual-Izquierdo, C; (...); Salinas, R
Article. 10.1002/jca.21894. 2021
Influence of Age on Treatment with Thrombopoietin Receptor Agonists in Patients with Immune Thrombocytopenia; A Retrospective Multicenter Study
Luisa Lozano, Maria; (...); Vicente Garcia, Vicente
Meeting Abstract. 10.1182/blood-2019-122237. 2019
INFLUENCE OF POST TPH CYCLOPHOSPHAMIDE ON TRANSFUSIONAL REQUIREMENTS AND TRANSFUSIONAL INDEPENDENCE IN PATIENTS SUBJECTED TO HLA IDENTICALLY MATCHED TPH
Navarro, Vicente Irene; (...); Orti, Verdet M. Consejo
Meeting Abstract. 2020
International Forum on Transfusion Practices in Haematopoietic Stem-Cell Transplantation: Responses
Solves, Pilar; (...); Dunbar, Nancy
Article. 10.1111/vox.13021. 2021
International Forum on Transfusion Practices in Haematopoietic Stem-Cell Transplantation: Summary
Solves, P; (...); Dunbar, N
Article. 10.1111/vox.13061. 2021
Ixazomib Plus Lenalidomide/Dexamethasone (IRd) Versus Lenalidomide /Dexamethasone (Rd) Maintenance after Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Results of the Spanish GEM2014MAIN Trial
Rosinol, Laura; (...); Blade Creixenti, Joan
Meeting Abstract. 10.1182/blood-2021-146798. 2021
Long Term Discontinuation of Eltrombopag after Remission in Primary Immune Thrombocytopenia: 8-Year Follow-up Data from 15 Spanish Centers
Jose Gonzalez-Lopez, Tomas; (...); Sanz, Miguel A.
Meeting Abstract. 10.1182/blood-2019-129274. 2019
Management of Adult Patients with Primary Immune Thrombocytopenia (ITP) in Clinical Practice: A Consensus Approach of the Spanish ITP Expert Group.
Mingot-Castellano ME; (...); González Porras JR
Article. 10.1155/2019/4621416. 2019
Management of chronic liver disease-associated severe thrombocytopenia in Spain: a view from the experts
Calleja-Panero, JL; (...); Gil, A
Article. 10.17235/reed.2020.6895/2020. 2020
Molecular profiling refines minimal residual disease-based prognostic assessment in adults with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.
Ribera J; (...); Ribera JM
Article. 10.1002/gcc.22788. 2019
Neutrophil extracellular traps (NETs) in patients with STEMI. Association with percutaneous coronary intervention and antithrombotic treatments.
Ferre-Vallverdu, Mari; (...); Moscardo, Antonio
Article. 10.1016/j.thromres.2022.03.002. 2022
Neutrophil extracellular traps levels are associated to severity and complications in community-acquired pneumonia
Jimenez, PG; (...); MENENDEZ, R
Meeting Abstract. 10.1183/13993003.congress-2020.2341. 2020
Noninfectious Neurologic Complications after Allogeneic Hematopoietic Stem Cell Transplantation
Balaguer-Rosello, A; (...); Sanz, Jaime
Article. 10.1016/j.bbmt.2019.05.024. 2019
Ofatumumab as Part of Reduced Intensity Conditioning in High Risk b-cell Lymphoma Patients: Results from a Prospective Multicenter Phase-II Trial
Cabrero, M; (...); Caballero, D
Meeting Abstract. 2020
Partial T Cell-Depleted Peripheral Blood Stem Cell Transplantation from HLA-Identical Sibling Donors for Patients with Severe Aplastic Anemia.
Sanz J; (...); Piñana JL
Article. 10.1016/j.bbmt.2019.08.020. 2020
Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia
Robak, T; (...); Jolles, S
Article. 10.1182/bloodadvances.2020002003. 2020
Platelet Transfusion: And Update on Challenges and Outcomes
Review. 10.2147/JBM.S234374. 2020
Predictive Factors for Thrombopoietin Receptor Agonist Free Responses in Chronic ITP Patients: A Multicenter Retrospective Study with Long-Term Follow-up
Luisa Lozano, Maria; (...); Vicente Garcia, Vicente
Meeting Abstract. 10.1182/blood-2019-125580. 2019
PREDICTORS OF TREATMENT FREE RESPONSES WITH THROMBOPOIETIN RECEPTOR AGONISTS IN PATIENTS WITH PTI
Lozano Almela, M. L.; (...); Vicente, V.
Meeting Abstract. 2019
Pure red cell aplasia after major or bidirectional ABO incompatible hematopoietic stem cell transplantation: to treat or not to treat, that is the question.
Marco-Ayala J; (...); Solves P
Review. 10.1038/s41409-020-01124-6. 2021
Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).
Abrisqueta, Pau; (...); Villanueva, Miguel
Article. 10.1016/j.clml.2021.07.022. 2021
Recommendations for the diagnosis and treatment of patients with thrombotic thrombocytopenic purpura.
Mingot Castellano, Maria Eva; (...); Grp Espanol Aferesis GEA
Practice Guideline. 10.1016/j.medcli.2021.03.040. 2022
Relevancia de la anfotericina B liposomal en el tratamiento de las infecciones fúngicas invasoras en pacientes oncohematológicos.
García-Vidal C, Vázquez L, Jarque I
Article. 10.1016/j.riam.2021.03.001. 2021
Results of the Ebmt Saawp Phase III Prospective Randomized Multicenter Race Study of Horse Atg and Ciclosporin with or Without Eltrombopag in Naive Saa Patients
de Latour, RP; (...); Risitano, A
Meeting Abstract. 2020
RESULTS OF THE PEGASUS PHASE III TRIAL FOR THE COMPARISON OF PEGCETACOPLAN WITH ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA
Jarque, Isidro; (...); Peffault, de latour Regis
Meeting Abstract. 2020
Rozanolixizumab, an Anti-FcRn Antibody: Final Results from a Phase II, Multiple-Dose Study in Patients with Primary Immune Thrombocytopenia
Robak, Tadeusz; (...); Jolles, Stephen
Meeting Abstract. 10.1182/blood-2019-129839. 2019
Signal transducer and activator of transcription 3 (STAT3) phosphorylation regulates thromboxane A 2 receptor activity in human platelets.
Latorre AM; (...); Moscardó A
Letter. 10.1111/bjh.16309. 2020
Soluble P-Selectin in Acute Exacerbations and Stable Bronchiectasis in Adults
Mendez, R; (...); Menendez, R
Letter. 10.1513/AnnalsATS.201902-140RL. 2019
THROMBOTIC EVENTS IN PATIENTS WITH PTI TREATED WITH THROMBOPOIETIN RECEPTOR AGONISTS. IDENTIFICATION OF PREDISPOSING FACTORS
Lozano Almela, M. L.; (...); Vicente, V.
Meeting Abstract. 2019
Transfusion management in multiple myeloma patients receiving daratumumab: Experience of a single tertiary care centre.
Solves P; (...); Carpio N
Article. 10.1016/j.transci.2019.09.011. 2020
Treatment patterns and outcomes in real-world transplant-ineligible patients newly diagnosed with multiple myeloma
Cejalvo, MJ; (...); de la Rubia, J
Article. 10.1007/s00277-021-04529-5. 2021
Unraveling IKZF1 Deletion Therapeutic Vulnerabilities in Adult B-Cell Precursor Acute Lymphoblastic Leukemia
Ribera, Jordi; (...); Maria Ribera, Josep
Meeting Abstract. 2020
USE OF CAPLACIZUMAB IN THE ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA
Dominguez Hernandez, L.; (...); Gomez Segui, I
Meeting Abstract. 2019
Use of eltrombopag for patients 65 years old or older with immune thrombocytopenia.
González-López TJ; (...); García-Frade LJ
Article. 10.1111/ejh.13370. 2020