Estudio en fase III, aleatorizado, doble ciego, controlado, para evaluar la eficacia y la seguridad de la terapia combinada con VX-121 en sujetos con fibrosis quística

Datos básicos

Código:
VX20-121-104
Protocolo:
VX20-121-104
EUDRACT:
2021-000713-17
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2023
Año de finalización:
2023
ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la seguridad y tolerabilidad a largo plazo de VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) en sujetos con fibrosis quística (FQ) Objetivos Secundarios: Evaluar la eficacia a largo plazo de VX-121/TEZ/D-IVA

Documentos

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Participantes

Grupos

Financiadores - Promotores

VERTEX PHARMACEUTICALS INCORPORATED

Resultados del Ensayo Clínico


[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

  • Open Access.

[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

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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

  • Open Access.

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

  • Open Access.

Best practices during COVID-19 pandemic in solid organ transplant programs in Spain.

Pascual, Julio; (...); Delgado, Juan F.

Article. 10.1016/j.trre.2023.100749. 2023

  • Open Access.

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

  • Open Access.

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


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


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

  • Open Access.

Cystic Fibrosis: From Salty Malediction to Possible Cure.

Sole, Amparo, Davies, Jane C., Quintana-Gallego, Esther

Editorial Material. 10.1016/j.arbres.2023.10.007. 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

  • Open Access.

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

  • Open Access.

Discordance between humoral and cellular immune responses to cytomegalovirus infection in CMV seropositive patients awaiting lung transplantation

Boada-Perez, Meritxell; (...); Gomez-Olles, Susana

Article. 10.3389/fimmu.2024.1445553. 2025

  • Open Access.

Evolving Indications for Heart-Lung Transplant in Spain.

Lopez-Vilella, Raquel; (...); Almenar Bonet, Luis

Article. 10.1016/j.transproceed.2022.10.003. 2022


Experience With Elexacaftor/Tezacaftor/Ivacaftor in Patients With Cystic Fibrosis and Advanced Disease.

Carrasco Hernandez, Laura; (...); Quintana Gallego, Esther

Article. 10.1016/j.arbres.2023.05.017. 2023

  • Open Access.

Fungal microbiota dynamics and its geographic, age and gender variability in patients with cystic fibrosis.

Martinez-Rodriguez, Sara; (...); Horra C

Article. 10.1016/j.cmi.2022.11.001. 2022


Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

  • Open Access.

Genomic characterization of MRSA recovered from people with cystic fibrosis during two Spanish multicentre studies (2013 and 2021).

Maruri-Aransolo A; (...); Caballero-Pérez JD

Article. 10.1093/jacamr/dlae160. 2024

  • Open Access.

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

  • Open Access.

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

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

  • Open Access.

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

  • Open Access.

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 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

  • Open Access.

Position paper: Models of post-transplant care for individuals with cystic fibrosis.

McKone, Edward; (...); Pilewski, Joseph M.

Article. 10.1016/j.jcf.2023.02.011. 2023

  • Open Access.

Pregnancy and fertility in people with cystic fibrosis following lung transplantation.

Taylor-Cousar JL, Sole A, Jain R

Article. 10.1097/MCP.0000000000001117. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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


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