ESTUDIO DE EXTENSIÓN DE FASE 3 PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DEL TRATAMIENTO A LARGO PLAZO CON LUMACAFTOR EN COMBINACIÓN CON IVACAFTOR EN SUJETOS DE 12 AÑOS O MÁS CON FIBROSIS QUÍSTICA, HOMOCIGÓTICOS O HETEROCIGÓTICOS PARA LA MUTACIÓN F508DEL-CF TR.
Datos básicos
- Protocolo:
- VX12-809-105
- EUDRACT:
- 2013-000604-41
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2014
- Año de finalización:
- 2016
Objetivos del proyecto
Observaciones: Estado Comité: FINALIZADO
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
Association of SNPs with the efficacy and safety of immunosuppressant therapy after heart transplantation
Sánchez-Lázaro I; (...); Aliño SF
Article. 10.2217/pgs.15.39. 2015
Burden of serious fungal infections in Spain
Rodriguez-Tudela JL; (...); University of Manchester in association with the LIFE program
Article. 10.1016/j.cmi.2014.07.013. 2015
Clinical response to long term enzyme replacement treatment in children, adolescent and adult patients with Hunter syndrome
Dalmau Serra J; (...); Cortell Aznar I
Article. 10.1016/j.medcli.2015.06.015. 2015
Component-resolved diagnosis: Performance of specific IgE to Alternaria compared to Alt a 1
Nieto M; (...); Mazon A
Letter. 10.1111/pai.12305. 2014
Cystic fibrosis in adult age
Lerin, M; (...); Alvarez-Sala, R
Article. 10.1016/j.rce.2014.05.001. 2014
Diagnostic power of echocardiographic speckle tracking of the tricuspid annular motion to assess right ventricular dysfunction
Alonso P; (...); Salvador A
Letter. 10.1016/j.ijcard.2013.12.157. 2014
Differential gene expression of C-type natriuretic peptide and its related molecules in dilated and ischemic cardiomyopathy. A new option for the management of heart failure
Tarazón E; (...); Portolés M
Letter. 10.1016/j.ijcard.2014.04.037. 2014
Does the calcineurin inhibitor have influence on cytomegalovirus infection in heart transplantation?
Rodríguez-Serrano M; (...); Salvador-Sanz A
Article. 10.1111/ctr.12282. 2014
Does the Calcineurin Inhibitor Have Influence on Cytomegalovirus Infection in Heart Transplantation?
Sanchez-Lazaro, I.; (...); Salvador-Sanz, A.
Article. 10.1016/j.healun.2014.01.067. 2014
ECONOMIC IMPACT LINKED TO THE REDUCTION OF EXACERBATIONS WHEN A TREATMENT REGIME WITH INHALED ANTIBIOTICS IS SWITCHED TO AZTREONAM LYSINE IN PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC PULMONARY INFECTION CAUSED BY PSEUDOMONAS AERUGINOSA
Sole A; (...); Casado MA
Meeting Abstract. 10.1016/j.jval.2014.08.1659. 2014
Erratum to "Practical guidelines: lung transplantation in patients with cystic fibrosis".
Hirche TO; (...); ECORN-CF Study Group
Article. 10.1155/2015/698460. 2015
Evaluation of humoral immunity profiles to identify heart recipients at risk for development of severe infections: A multicenter prospective study
Sarmiento, E; (...); Carbone, J
Article. 10.1016/j.healun.2016.10.004. 2017
Functional Outcomes After Lung Transplant in Chronic Obstructive Pulmonary Disease
Navarro, JC; (...); Alarcon, JP
Article. 10.1016/j.arbres.2014.06.012. 2015
Gene expression network analysis reveals new transcriptional regulators as novel factors in human ischemic cardiomyopathy
Herrer I; (...); Rivera M
Article. 10.1186/s12920-015-0088-y. 2015
Genotype and Allele Frequencies of Drug-Metabolizing Enzymes and Drug Transporter Genes Affecting Immunosuppressants in the Spanish White Population
Bosó V; (...); Aliño SF
Article. 10.1097/FTD.0b013e3182a94e65. 2014
Hyperkalemia in heart failure patients: current challenges and future prospects
Lopez-Vilella, R; (...); Almenar-Bonet, L
Review. 10.2147/RRCC.S75680. 2016
Impact of Single Nucleotide Polymorphisms (SNPs) on Immunosuppressive Therapy in Lung Transplantation
Ruiz J; (...); Aliño SF
Article. 10.3390/ijms160920168. 2015
Incidence of Development of Obesity After Heart Transplantation According to the Calcineurin Inhibitor
López-Vilella R; (...); Montero-Argudo A
Article. 10.1016/j.transproceed.2014.11.025. 2015
Incidence of Development of Obesity After Heart Transplantation According to the Calcineurin Inhibitor (vol 47, pg 127, 2015)
Lopez-Vilella, R.; (...); Montero-Argudo, A.
Article. 10.1016/j.transproceed.2015.09.023. 2015
Intravenous sildenafil in right ventricular dysfunction with pulmonary hypertension following a heart transplant.
Bonet LA; (...); Sanz AS
Article. 10.5301/HEART.2014.12492. 2014
Management of pulmonary exacerbations in cystic fibrosis: still an unmet medical need in clinical practice
Justicia JL; (...); Máiz L
Review. 10.1586/17476348.2015.1016504. 2015
Measurements of Functional Responses in Human Primary Lung Cells as a Basis for Personalized Therapy for Cystic Fibrosis.
Awatade, NT; (...); Amaral, MD
Article. 10.1016/j.ebiom.2014.12.005. 2015
Nocardia farcinica lung infection in a patient with cystic fibrosis and a lung transplant.
Chacón CF; (...); Ansotegui E
Article. 10.1016/j.redar.2014.04.010. 2015
Possible recurrence of symptoms after discontinuation of omalizumab in anti-IgE-assisted desensitization to egg
Lafuente I; (...); Nieto A
Letter. 10.1111/pai.12259. 2014
Practical guidelines: lung transplantation in patients with cystic fibrosis.
Hirche TO; (...); ECORN-CF Study Group
Article. 10.1155/2014/621342. 2014
Prevalence and Diagnosis of Chronic Kidney Disease in Maintenance Lung Transplant Patients: ICEBERG Study
Solé A; (...); Santos F
Article. 10.1016/j.transproceed.2015.04.097. 2015
Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries
Quittner AL; (...); Barker D
Article. 10.1136/thoraxjnl-2014-205983. 2014
Prevalence of fragmented QRS complex and factors related with its occurrence
Martinez-Dolz, L.; (...); Almenar-Bonet, L.
Article. 2014
Progresos en el diagnostico de la alergia.
Nieto A, Nieto M, Mazón A
Abstract of Published Item. 2014
Protocolo de seguimiento de los pacientes con displasia broncopulmonar.
Perez Tarazona S; (...); Vilella Sabate M
Article. 10.1016/j.anpedi.2015.04.020. 2016
Report of the European Respiratory Society/European Cystic Fibrosis Society task force on the care of adults with cystic fibrosis
Elborn JS; (...); Blasi F
Article. 10.1183/13993003.00592-2015. 2016
Risk factors for bronchiolitis, recurrent wheezing, and related hospitalization in preterm infants during the first year of life
Pérez-Yarza EG; (...); SAREPREM 3235 investigators
Article. 10.1111/pai.12414. 2015
Single Nucleotide Polymorphisms, SNPs, Associated With the Efficacy and Security of Immunosuppressive Treatment in Heart Transplantation
Sanchez-Lazaro, I.; (...); Salvador-Sanz, A.
Article. 10.1016/j.healun.2014.01.392. 2014
Spanish Consensus on the Prevention and Treatment of Pseudomonas aeruginosa Bronchial Infections in Cystic Fibrosis Patients
Cantón R; (...); Solé A
Article. 10.1016/j.arbres.2014.09.021. 2015
Spanish Heart Transplant Registry. 29th Official Report of the Spanish Society of Cardiology Working Group on Heart Failure
Gonzalez-Vilchez, F; (...); Representation Equipos Espanoles T
Article. 10.1016/j.recesp.2018.07.020. 2018
Spanish Heart Transplant Registry. 30th Official Report of the Spanish Society of Cardiology Working Group on Heart Failure (1984-2018)
Gonzalez-Vilchez, F; (...); Abella-Anton, R
Article. 10.1016/j.rec.2019.09.005. 2019
Spanish Heart Transplant Registry. 31th Official Report of the Heart Failure Association of the Spanish Society of Cardiology.
González-Vilchez F; (...); Groba Marco MDV
Article. 10.1016/j.rec.2020.06.035. 2020
The 2015 International Society for Heart and Lung Transplantation Guidelines for the management of fungal infections in mechanical circulatory support and cardiothoracic organ transplant recipients: Executive summary
Husain S; (...); Morrissey O
Article. 10.1016/j.healun.2016.01.007. 2016
Thrombotic microangiopathy associated with tacrolimus in lung transplantation.
Reig Mezquida JP; (...); Pastor Guillem J
Article. 10.1016/j.arbres.2014.07.004. 2015
Use of a "CNI holidays" strategy in acute renal dysfunction late after heart transplant. Report of two cases.
Article. 2014