ESTUDIO DE FASE 3, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE LUMACAFTOR EN COMBINACIÓN CON IVACAFTOR EN PACIENTES DE 12 O MÁS AÑOS DE EDAD CON FIBROSIS QUÍSTICA Y HOMOCIGÓTICOS PARA LA MUTACIÓN F508DEL-CFTR.

Datos básicos

Protocolo:
VX12-809-104
EUDRACT:
2012-003990-24
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2013
Año de finalización:
2014
ENSAYO CLÍNICO INTERNACIONAL

Documentos

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Participantes

Grupos

Financiadores - Promotores

VERTEX PHARMACEUTICALS INC.

Resultados del Ensayo Clínico


[Disseminated non-tuberculous mycobacterial infection in a patient with hyper-IgE syndrome].

Romero Rubio MT; (...); Santos Serrano L

Letter. 10.1016/j.anpedi.2013.01.017. 2013


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


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


EFFECT OF CYP3A5 GENOTYPE ON TACROLIMUS DOSE REQUIREMENT, NEPHROTOXICITY AND ACUTE REJECTION IN KIDNEY TRANSPLANTATION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF OBSERVATIONAL STUDIES

Rojas, L.; (...); Alino, S. F.

Article. 2013


EFFECTS OF POLYMORPHIMS OF CYP3A5 AND ABCB1 GENES ON CHRONIC NEPHROPATHY: COHORT STUDY

Rojas, L.; (...); Alino, S. F.

Article. 2013


Epidemiology, diagnosis and treatment of fungal respiratory infections in the critically ill patient.

Garnacho-Montero J; (...); Barberán J

Article. 2013


Estudio de utilizacion de boceprevir y telaprevir para el tratamiento de la hepatitis C cronica.

Marrero-Álvarez P; (...); Poveda-Andrés JL

Abstract of Published Item. 10.7399/FH.2014.38.1.1128. 2014

  • Open Access.

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


Evaluation of omalizumab prescription for asthma patients. Adequacy to the recommendations of the regulatory agencies and asthma guidelines

de Rojas, H. F.; (...); Nieto Garcia, A.

Meeting Abstract. 2013


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


Heart transplantation and metabolic syndrome: which calcineurin inhibitor most promotes its development?

Martinez-Dolz, L.; (...); Salvador-Sanz, A.

Article. 2013


High-permeability region size on perfusion CT predicts hemorrhagic transformation after intravenous thrombolysis in stroke

Puig, J; (...); Castellanos, M

Article. 10.1371/journal.pone.0188238. 2017

  • Open Access.

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 basal heart rate on long-term prognosis of heart transplant patients.

Melero-Ferrer JL; (...); Salvador-Sanz A

Article. 10.1111/tri.12082. 2013


Intravenous sildenafil in right ventricular dysfunction with pulmonary hypertension following a heart transplant.

Bonet LA; (...); Sanz AS

Article. 10.5301/HEART.2014.12492. 2014


Meta-analysis and systematic review of the effect of the donor and recipient CYP3A5 6986A>G genotype on tacrolimus dose requirements in liver transplantation.

Rojas LE; (...); Aliño SF

Article. 10.1097/FPC.0b013e3283642fb3. 2013


Metabolic syndrome in heart transplantation: impact on survival and renal function.

Martínez-Dolz L; (...); Montero JA

Article. 10.1111/tri.12149. 2013


Practical guidelines: lung transplantation in patients with cystic fibrosis.

Hirche TO; (...); ECORN-CF Study Group

Article. 10.1155/2014/621342. 2014


Selective ophthalmic intra-arterial melphalan therapy for advanced retinoblastoma: implementation and outcomes of a new chemotherapy protocol.

Valero García S; (...); Poveda Andrés JL

Article. 10.1177/1078155212457964. 2013


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


SNPs and taxane toxicity in breast cancer patients

Bosó V; (...); Aliño SF

Article. 10.2217/PGS.14.127. 2014


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


Tolvaptan in hyponatremic patients with heart failure: initial experience

Martinez-Dolz, L.; (...); Salvador-Sanz, A.

Article. 2013


Trasplante pulmonar en la linfangioleiomiomatosis esporádica. Estudio de 7 casos.

Ansótegui Barrera E; (...); Padilla Alarcón J

Abstract of Published Item. 10.1016/j.medcli.2013.05.036. 2013


Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature

Lizan, L; (...); Polanco, C

Review. 10.2147/PPA.S67253. 2014

  • Open Access.

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