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
ENSAYO CLÍNICO INTERNACIONAL

Objetivos del proyecto

Observaciones: Estado Comité: FINALIZADO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

VERTEX PHARMACEUTICALS INC.

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

  • Open Access.

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

  • Open Access.

Impact of Single Nucleotide Polymorphisms (SNPs) on Immunosuppressive Therapy in Lung Transplantation

Ruiz J; (...); Aliño SF

Article. 10.3390/ijms160920168. 2015

  • Open Access.

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


Inhaled medication and inhalation devices for lung disease

Solé A, Girón RM

Article. 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

  • Open Access.

Mold infections in lung transplants

Sole, A, Ussetti, P

Review. 10.1016/j.riam.2014.07.001. 2014


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.

Alonso P; (...); Montero A

Article. 2014


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