Portal de recerca
Estudio de fase IIb, multicéntrico, aleatorizado y con doble enmascaramiento de la seguridad y la eficacia de TAK-755 (rADAMTS13) con plasmaféresis (PF) mínima o nula en el tratamiento de la púrpura trombocitopénica trombótica inmunitaria (PTTi).
Dades bàsiques
- Protocol:
- TAK-755-2001
- EURDRACT:
- 2022-001940-36
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Objectius del projecte
Objetivo Principal: Evaluar la seguridad de TAK-755 en el tratamiento de la PTTi Objetivos Secundarios: 1. Evaluar la eficacia de TAK-755 en la consecución de una respuesta clínica con y sin PF durante el estudio después de un acontecimiento agudo de púrpura trombocitopénica trombótica (PTT). 2. Evaluar los fracasos de tratamiento. 3. Evaluar la eficacia de TAK-755 en la prevención de la recidiva de la PTTi, la reagudización y la recaída. 4. Evaluar los cambios en los biomarcadores de daño orgánico. 5. Evaluar la durabilidad de la respuesta clínica. 6. Evaluar el antígeno y la actividad de ADAMTS13 a lo largo del tiempo. 7. Evaluar el antígeno y la actividad del factor de von Willebrand (VWF) con el tiempo.
Documents
- No hi ha documents
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
"INTUPROS": una oportunidad para reflexionar y mejorar.
Viviani, Andrea, Vicent, Carlos, Castellanos-Ortega, Alvaro
Letter. 10.1016/j.medine.2024.04.014. 2024
? INTUPROS ? : An opportunity to reflect upon and improve
Viviani, Andrea, Vicent, Carlos, Castellanos-Ortega, Alvaro
Letter. 10.1016/j.medin.2024.03.014. 2024
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study.
Rios-Tamayo, Rafael; (...); Mateos, Maria Victoria
Article. 10.1080/16078454.2023.2178997. 2023
ADAMTS13 RECOVERY IN ACUTE THROMBOTIC THROMBOCYTOPENIC PURPURA AFTER CAPLACIZUMAB THERAPY. THE SPANISH REGISTRY.
Mingot-Castellano, Maria Eva; (...); Pascual Izquierdo, Cristina
Article. 10.1182/blood.2023022725. 2024
Alnuctamab (ALNUC; BMS-986349; CC-93269), a 2+1 B- Cell Maturation Antigen (BCMA) x CD3 T-Cell Engager (TCE), Administered Subcutaneously (SC) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 First-in-Human Clinical Study
Bar, Noffar; (...); Costa, Luciano
Meeting Abstract. 10.1182/blood-2023-180013. 2023
Analysis of Peripheral Blood and Bone Marrow Residual Disease Dynamics during Intensive Treatment and Maintenance in Patients with Multiple Myeloma Included in the GEM12MENOS65 and GEM14MAIN Clinical Trials
Puig, Noemi; (...); Victoria Mateos, Maria
Meeting Abstract. 10.1182/blood-2023-184837. 2023
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Belantamab Mafodotin in Combination with VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients: Results from the Phase II, Open Label, Multicenter, GEM-BELA-VRd Trial
Gonzalez-Calle, Veronica; (...); Mateos, Maria-Victoria
Meeting Abstract. https://doi.org/10.1182/blood-2022-162584. 2024
Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain.
de la Rubia, Javier; (...); Alegre, Adrian
Article. 10.3390/cancers15112964. 2023
Caplacizumab Frontline Added to Therapeutic Plasma Exchange and Immunosuppression Prevents Unfavorable Outcomes in Immune-Mediated TTP: An International Real-World Study of the TTP-IWG (The Capla 500 Project)
Coppo, Paul; (...); Scully, Marie
Meeting Abstract. 10.1182/blood-2023-179316. 2023
Caplacizumab Treatment in Elderly Patients with iTTP: Updated Experience from the Spanish TTP Registry
Gomez Segui, Ines; (...); De La Rubia, Javier
Meeting Abstract. 10.1182/blood-2023-180970. 2023
Cefiderocol pharmacokinetics in critically ill patients undergoing ECMO support.
Marín-Cerezuela M; (...); Ramirez P
Letter. 10.1186/s13054-024-05126-4. 2024
Cis-Acting Splicing-Associated Variants Can Redefine the Molecular Signature of Genes Commonly Mutated in Acute Myeloid Leukemia
Morote-Faubel, Mireya; (...); Cervera, Jose
Meeting Abstract. 10.1182/blood-2023-177571. 2023
Clinical Characteristics, Treatment Approach and Long-Term Outcomes of 678 Patients with Symptomatic Waldenstrom's Macroglobulinemia: Comprehensive Insights from a Spanish Registry of IgM Gammapathies
Askari, Elham; (...); Garcia-Sanz, Ramon
Meeting Abstract. 10.1182/blood-2023-189581. 2023
CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.
Article. 10.1016/j.jtct.2024.01.082. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
Correction: Vitamin C and folate status in hereditary fructose intolerance.
Cano A; (...); de Las Heras J
Correction. 10.1038/s41430-023-01334-3. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Curative Strategy for High-Risk Smoldering Myeloma: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed by Transplant, KRd Consolidation, and Rd Maintenance.
Mateos, Maria-Victoria; (...); San-Miguel, Jesus F
Article. 10.1200/JCO.23.02771. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Article. 10.3390/cancers15113039. 2023
Definition and Clinical Significance of the Monoclonal Gammopathy of Undetermined Significance-Like Phenotype in Patients With Monoclonal Gammopathies.
Burgos, Leire; (...); Paiva, Bruno
Article. 10.1200/JCO.22.01916. 2023
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Effect of a competence based medical education program on training quality in Intensive Care Medicine. COBALIDATION TRIAL.
Castellanos-Ortega, Alvaro; (...); Garcia-Ros, Rafael
Article. 10.1016/j.medine.2024.502126. 2025
Effect of autologous umbilical cord blood transfusion in the development of retinopathy of prematurity: randomized clinical trial - study protocol.
Torrejon-Rodriguez L; (...); Aguar Carrascosa M
Article. 10.3389/fped.2023.1269797. 2023
Effect of Caplacizumab in the Recovery of ADAMTS13 Level in Patients with Autoimmune Thrombotic Thrombocytopenic Purpura. Analysis from the Spanish Registry (REPTT)
Eva Mingot, Maria; (...); Del Rio Garma, Julio
Meeting Abstract. 10.1182/blood-2023-182876. 2023
Enhancing Cytogenetic Diagnostics: Incorporating Optical Genome Mapping in the Laboratory Routine
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Meeting Abstract. 10.1182/blood-2023-180691. 2023
Epidemiology of Hereditary Thrombotic Thrombocytopenic Purpura (TTP) in Spain: Preliminary Results of a Study of the Spanish TTP Registry (REPTT)
Segui, Ines Gomez; (...); Garma, Julio Del Rio
Meeting Abstract. 2024
Gastric Bleeding in Stem Cell Transplantation: A Focus on Gastric Vascular Ectasia Under Post-Transplant Cyclophosphamide, Sirolimus, and Mycophenolate Mofetil Prophylaxis.
Eirís J; (...); Sanz J
Article. 10.1016/j.jtct.2024.10.009. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Genomic profiling of high-risk smoldering myeloma patients treated with a curative strategy: a biological study of the phase II GEM CESAR clinical trial
Medina, Alejandro; (...); Garcia-Sanz, Ramon
Meeting Abstract. 2023
GERMLINE PREDISPOSITION TO MYELOID MALIGNANCIES IN A CONSECUTIVE COHORT OF 183 PATIENTS
Santiago, M.; (...); Cervera-Zamora, J.
Meeting Abstract. 10.1016/j.leukres.2023.107247. 2023
High-risk cytogenetic abnormalities in multiple myeloma: PETHEMA-GEM experience
Rodriguez-Otero, Paula; (...); Gutierrez, Norma
Meeting Abstract. 2023
High-risk cytogenetic abnormalities in multiple myeloma: PETHEMA-GEM experience
Gonzalez-Calle, Veronica; (...); Gutierrez, Norma C.
Article. 10.1002/hem3.70031. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
IDIOPATHIC UPPER GASTROINTESTINAL BLEEDING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: AN UNPRECEDENTED COMPLICATION
Eiris, Juan; (...); Balaguer-Rosello, Aitana
Meeting Abstract. 2024
Immune reconstitution after single-unit umbilical cord blood transplantation using anti-thymoglobulin and myeloablative conditioning in adults with hematological malignancies.
Article. 10.1007/s00277-024-05758-0. 2024
Immune thrombotic thrombocytopenic purpura in older patients: Results from the Spanish TTP Registry (REPTT).
Gomez-Segui, I; (...); de la Rubia Comos, J
Article. 10.1111/bjh.19109. 2023
Immunotherapy in multiple myeloma.
Asensi Cantó P, Arnao Herraiz M, de la Rubia Comos J
Article. 10.1016/j.medcli.2023.11.019. 2024
IMPACT OF POSTTRANSPLANT CYCLOPHOSPHAMIDE ON TRANSFUSION REQUIREMENTS IN HLA MATCHED SIBLING PERIPHERAL BLOOD STEM CELL TRANSPLANTATION.
Marco-Ayala, Javier; (...); Solves, Pilar
Article. 10.1016/j.jtct.2023.01.009. 2023
Improved outcomes in allo-HCT for multiple myeloma patients with thiotepa-busulfan-fludarabine conditioning regimen and post-transplant cyclophosphamide, sirolimus and mycophenolate mofetil
de la Rubia, Javier; (...); Sanz, Miguel
Meeting Abstract. 2023
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 2023
Incidence, risk factors and therapy response of acute graft-versus-host disease after myeloablative hematopoietic stem cell transplantation with posttransplant cyclophosphamide.
Asensi Cantó P; (...); Sanz J
Article. 10.1038/s41409-024-02391-3. 2024
Incidence, risk factors, and outcomes of BK hemorrhagic cystitis in hematopoietic stem cell transplantation from HLA-matched and haploidentical donors with post-transplant cyclophosphamide.
Chorao, Pedro; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2024.12.006. 2024
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Isolated and Dynamic Peripheral Blood Residual Disease Status Characterized By Mass Spectrometry Predicts Outcome in Patients with High Risk Smoldering Multiple Myeloma Treated in the GEM-CESAR Trial
Puig, Noemi; (...); Victoria Mateos, Maria
Meeting Abstract. 10.1182/blood-2023-182964. 2023
Longitudinal outcome over four decades of allogeneic stem cell transplantation: a single center experience.
Sanz, Miguel Angel; (...); Sanz, Jaime
Article. 10.1038/s41409-024-02319-x. 2024
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
NEUROLOGIC COMPLICATIONS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH CALCINEURIN-FREE GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS
Balaguer Rosello, Aitana; (...); Sanz, Jaime
Meeting Abstract. 2023
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Patient safety, what does clinical simulation and teaching innovation contribute?
Broch Porcar, Maria Jesus, Castellanos-Ortega, Alvaro
Article. 10.1016/j.medine.2024.04.012. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Real world evaluation of teclistamab in patients with RRMM: results from the IMF immunotherapy database project
Costa, Luciano; (...); Wong, Sandy
Meeting Abstract. 2023
Real-World Experience in Extracorporeal photopheresisfor adults with graft-versus-host disease.
Asensi Cantó P; (...); Gómez-Seguí I
Article. 10.1016/j.jtct.2023.09.001. 2023
Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part I: update on laboratory tests for the study of monoclonal gammopathies.
Cardenas, Maria C.; (...); Cruz-Iglesias, Elena
Article. 10.1515/cclm-2023-0326. 2023
Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part II: methodological and clinical recommendations for the diagnosis and follow-up of monoclonal gammopathies
Cardenas, Maria C.; (...); Cruz-Iglesias, Elena
Article. 10.1515/cclm-2023-0325. 2023
Reduced incidence of neurologic complications after allogeneic hematopoietic stem cell transplantation with calcineurin-free graft-versus-host disease prophylaxis.
Balaguer-Rosello, Aitana; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2023.07.008. 2023
Reply to "Patient safety, what does clinical simulation and teaching innovation contribute?"
Broch Porcar, Maria Jesus, Castellanos-Ortega, Alvaro
Letter. 10.1016/j.medine.2024.07.013. 2024
RUXOLITINIB IN ACUTE AND CHRONIC GRAFT-VERSUS RECEPTOR DISEASE: LONG-TERM REAL-LIFE EXPERIENCE IN A MULTI-CENTRE STUDY IN PEDIATRIC POPULATION
Escamilla Gomez, Virginia; (...); Garcia Gutierrez, Valentin
Meeting Abstract. 2024
Selective IgA Deficiency and Blood Component Transfusion: In Search of the Lost Evidence
Solves, Pilar; (...); de la Rubia, Javier
Article. 10.3390/hemato5020009. 2024
Should we consider caplacizumab as routine treatment for acute thrombotic thrombocytopenic purpura? An expert perspective on the pros and cons.
Seguí IG; (...); de la Rubia J
Article. 10.1080/17474086.2024.2318347. 2024
Single-point and kinetics of peripheral residual disease by mass spectrometry to predict outcome in patients with high risk smoldering multiple myeloma included in the GEM-CESAR trial.
Puig N; (...); Mateos MV
Article. 10.3324/haematol.2024.285742. 2024
T-cell Depleted Peripheral Blood versus Unmanipulated Bone Marrow in Matched Sibling Transplantation for Aplastic Anemia.
Chorao, Pedro; (...); Sanz, Jaime
Article. 10.1016/j.jtct.2023.01.016. 2023
The genomic profiling of high-risk smoldering myeloma patients treated with an intensive strategy unveils potential markers of resistance and progression.
Medina-Herrera A; (...); Garcia-Sanz R
Article. 10.1038/s41408-024-01053-3. 2024
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Transfusion Burden in Allogeneic Hematopoietic Stem Cell Transplantation over Time: Experience from a Single Institution.
Solves, Pilar; (...); Sanz, Jaime
Article. 10.3390/jcm12103467. 2023
Use of optical genome mapping in the cytogenetic diagnosis of multiple myeloma
de la Rubia, Javier; (...); Such, Esperanza
Meeting Abstract. 2023
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023