Portal de recerca
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia.
Dades bàsiques
- Protocol:
- INCB50465-309
- EURDRACT:
- 2021-002844-66
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2023
Objectius del projecte
Objetivo Principal: To evaluate the efficacy of parsaclisib in the treatment of participants with wAIHA. Objetivos Secundarios: Key secondary objective: •To further evaluate parsaclisib in the treatment of participants with wAIHA. Other secondary objectives: •To further evaluate the efficacy of parsaclisib in the treatment of participants with wAIHA. •To evaluate the safety and tolerability of parsaclisib in participants with wAIHA. Exploratory objectives: •To further evaluate the efficacy of parsaclisib. •To evaluate the participant's quality of life and other PROs. •To characterize serum biomarkers and/or leukocyte profiles in participants with wAIHA treated with parsaclisib. •To evaluate PK of parsaclisib in participants with wAIHA.
Documents
- No hi ha documents
Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A simple score to predict early severe infections in patients with newly diagnosed multiple myeloma
Encinas, Cristina; (...); Martinez-Lopez, Joaquin
Article. 10.1038/s41408-022-00652-2. 2022
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
Autologous stem cell transplantation as consolidation of first-line chemotherapy in patients with peripheral T-cell lymphoma: a multicenter GELTAMO/FIL study.
García-Sancho AM; (...); Caballero D
Article. 10.3324/haematol.2021.279426. 2022
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
Fernandez Rivera C; (...); Hernandez D
Article. 10.1111/ctr.14550. 2022
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
Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.
Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina
Article. 10.1093/mmy/myac038. 2022
Chronic liver disease-associated severe thrombocytopenia in Spain: Results from a retrospective study using machine learning and natural language processing.
Calleja-Panero, Jose Luis; (...); Gonzalez Calvo, Jose
Article. 10.1016/j.gastrohep.2023.05.010. 2023
Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.
Salinas P; (...); Escaned J
Article. 10.1016/j.carrev.2021.11.015. 2021
Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia.
Peffault de Latour R; (...); Risitano AM
Article. 10.1056/NEJMoa2109965. 2022
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
Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.
de la Rubia J; (...); Bonanad, Santiago
Article. 10.1016/j.jgo.2022.10.016. 2022
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.
Vallejo, Carlos; (...); Peman, Javier
Article. 10.3390/jof9060628. 2023
Immunoparesis Recovery in Transplant-Ineligible Newly Diagnosis Multiple Myeloma Patients: An Independent Prognosis Factor That Could Complement Prognostic Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-166826. 2022
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
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
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
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
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
Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2
Kim, Won-Seog; (...); Walewski, Jan
Meeting Abstract. 10.1182/blood-2022-158406. 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
Panel Sequencing for Clinically Oriented Variant Screening and Copy Number Detection in Chronic Lymphocytic Leukemia Patients
Ibanez, Mariam; (...); Luna I
Article. 10.3390/diagnostics12040953. 2022
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
Prognostic Value of Serum Paraprotein Response Kinetics in Patients With Newly Diagnosed Multiple Myeloma.
Tamariz-Amador, Luis-Esteban; (...); Troconiz, Inaki F.
Article. 10.1016/j.clml.2022.04.024. 2022
Real-world effectiveness of caplacizumab vs standard of care in immune thrombotic thrombocytopenic purpura.
Pascual Izquierdo, Maria Cristina; (...); Del Rio-Garma, Julio
Article. 10.1182/bloodadvances.2022008028. 2022
Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Is an Independent Prognostic Factor for Multiple Myeloma and Could Complement Prognosis Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-167247. 2022
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
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 association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
Transfusion Burden in Allogeneic Hematopoietic Stem Cell Transplantation over Time: Experience from a Single Institution.
Solves, Pilar; (...); Sanz, Jaime
Article. 10.3390/jcm12103467. 2023