ENSAYO CLÍNICO DE FASE III, RANDOMIZADO, CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE MK 8228 (LETERMOVIR) EN LA PREVENCIÓN DE LA INFECCIÓN CLÍNICAMENTE SIGNIFICATIVA POR CITOMEGALOVIRUS (CMV) EN ADULTOS CMV SEROPOSITIVOS QUE VAYAN A REC IBIR UN TRASPLANTE ALOGÉNICO DE CÉLULAS MADRE HEMATOPOYÉTICAS.

Datos básicos

Protocolo:
8228-001
EUDRACT:
2013-003831-31
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

MERCK SHARP & DOHME CORP., FILIAL DE MERCK & CO., INC.

Resultados del Ensayo Clínico


[Farewell open letter to SEFH members].

Poveda Andrés JL

Editorial Material. 10.7399/fh.2015.39.6.10128. 2015

  • Open Access.

A systematic review and meta-analysis of the impact of WT1 polymorphism rs16754 in the effectiveness of standard chemotherapy in patients with acute myeloid leukemia

Megías-Vericat JE; (...); Aliño SF

Article. 10.1038/tpj.2015.80. 2016


Advances in haploidentical stem cell transplantation for hematologic malignancies

Montoro J; (...); Sanz MA

Review. 10.3109/10428194.2016.1167204. 2016


Aflibercept in exudative age related macular degeneration refractory to ranibizumab.

Ruiz Ramos J; (...); Gallego-Pinazo R

Article. 10.1016/j.oftal.2015.07.018. 2015


Assessment of the quality of sample labelling for clinical research.

Pérez-Huertas P; (...); Poveda-Andrés JL

Article. 10.7399/fh.2016.40.2.9753. 2016

  • Open Access.

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


Autoimmune cytopenias after umbilical cord blood transplantation in adults with hematological malignancies: a single-center experience

Sanz J; (...); Sanz GF

Article. 10.1038/bmt.2014.107. 2014


Biosimilares: viejas polemicas con nuevos argumentos.

Poveda-Andrés JL, Bosó-Ribelles V

Editorial Material. 10.7399/fh.2015.39.3.8978. 2015

  • Open Access.

Bloodstream Infections in Adult Patients Undergoing Cord Blood Transplantation from Unrelated Donors after Myeloablative Conditioning Regimen

Sanz J; (...); Sanz GF

Article. 10.1016/j.bbmt.2014.12.038. 2015


Calidad y Legibilidad de la Hoja de Informacion al Paciente en Estudios con Analisis Farmacogenetico.

Ruiz Ramos J; (...); Poveda Andrés JL

Article. 2015


Clinical evaluation of rituximab treatment for neuromyelitis optica

Fernández-Megía MJ; (...); Poveda-Andrés JL

Article. 10.1016/j.nrl.2014.09.001. 2015

  • Open Access.

Clinical experiences with cannabinoids in spasticity management in multiple sclerosis

Lorente Fernández L; (...); Casanova-Estruch B

Article. 10.1016/j.nrl.2013.06.014. 2014

  • Open Access.

Comparative Study of Post-Transplant Lymphoproliferative Disorders after Solid Organ Transplantation Versus Hematopoietic Stem Cell Transplantation

Romero, Samuel, Sr.; (...); Sanz, Miguel Angel

Article. 2015


Comparison of outcomes after unrelated cord blood and unmanipulated haploidentical stem cell transplantation in adults with acute leukemia

Ruggeri A; (...); ALWP-EBMT study

Article. 10.1038/leu.2015.98. 2015


Cost-effectiveness of methoxy polyethylene glycolepoetin beta versus conventional epoetin in the treatment of anaemia secondary to chronic kidney disease in clinical practice

Lorente-Fernandez, L; (...); Poveda-Andres, JL

Article. 10.1136/ejhpharm-2013-000426. 2015


C-Reactive Protein at Discharge, Diabetes Mellitus and >= 1 Hospitalization During Previous Year Predict Early Readmission in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Crisafulli E; (...); Menéndez R

Article. 10.3109/15412555.2014.933954. 2015


Diffusion tensor imaging as a prognostic biomarker for motor recovery and rehabilitation after stroke

Puig, J; (...); Pedraza, S

Review. 10.1007/s00234-017-1816-0. 2017


Dose banding aplicado a la elaboracion de antineoplasicos: una revision narrativa de la literatura.

Pérez Huertas P; (...); Poveda Andrés JL

Article. 10.7399/fh.2015.39.4.8839. 2015

  • Open Access.

Drug Interaction Between Oral Cyclosporine Modified and Iron

Domingo-Chiva, E; (...); Poveda-Andres, JL

Article. 10.1177/1060028013514734. 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.

Eculizumab for the treatment of pregnancy-related atypical hemolytic uremic syndrome

Cañigral C; (...); Sanz MA

Letter. 10.1007/s00277-013-1970-3. 2014


Effect of CD8(+) Cell Content on Umbilical Cord Blood Transplantation in Adults with Hematological Malignancies

Moscardó F; (...); Sanz GF

Article. 10.1016/j.bbmt.2014.06.038. 2014


Effect of CYP3A5*3 on kidney transplant recipients treated with tacrolimus: a systematic review and meta-analysis of observational studies

Rojas L; (...); Aliño SF

Article. 10.1038/tpj.2014.38. 2015


Engraftment kinetics and graft failure after single umbilical cord blood transplantation using a myeloablative conditioning regimen

Ruggeri A; (...); Netcord

Article. 10.3324/haematol.2014.109280. 2014

  • Open Access.

Epstein-Barr virus-associated posttransplant lymphoproliferative disorder after allogeneic stem cell transplantation

Sanz J, Andreu R

Review. 10.1097/CCO.0000000000000119. 2014


Executive summary of the GESIDA/National AIDS Plan Consensus Document on antiretroviral therapy in adults infected by the human immunodeficiency virus (updated January 2015)

Expert Panel of GESIDA and the National AIDS Plan; (...); Rivero A

Article. 10.1016/j.eimc.2015.03.017. 2015


Experience in the management of immunosuppressant treatment with hepatitis C virus protease inhibitors

Ruiz Ramos J; (...); Poveda Andrés JL

Article. 10.1016/j.gastrohep.2014.05.004. 2014


EXPERTS CONSENSUS ON THE FUTURE OF RARE DISEASES CARE AND ORPHAN DRUGS ACCESS IN SPAIN: A DELPHI STUDY

Paz S; (...); Urcelay J

Meeting Abstract. 10.1016/j.jval.2015.09.2016. 2015

  • Open Access.

Ex-vivo T-cell depleted peripheral blood stem cell transplantation from HLA-matched sibling donors for the treatment of severe aplastic anemia

Cano-Ferri, I.; (...); Sanz, G.

Meeting Abstract. 2015


Hazardous drugs: new challenges, new opportunities.

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

Article. 10.7399/fh.2016.40.2.10462. 2016

  • Open Access.

Hematologic neoplasms: interpreting lung findings in chest computed tomography.

Calvillo Batllés P; (...); Compte Torrero L

Article. 10.1016/j.rx.2015.07.003. 2015


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.

Impact of natural-killer immune reconstitution on the development of cytomegalovirus infection, non-relapse mortality, and graft versus host disease after allogeneic stem cell transplantation

Rodriguez-Veiga, R.; (...); Sanz, M. A.

Meeting Abstract. 2015


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

Ruiz J; (...); Aliño SF

Article. 10.3390/ijms160920168. 2015

  • Open Access.

Impact of Transporter Genes Polymorphisms in Standard Induction of Acute Myeloid Leukemia

Eduardo Megias, Juan; (...); Angel Sanz, Miguel

Meeting Abstract. 2015


Incidence and risk factors of post-engraftment invasive fungal disease in adult allogeneic hematopoietic stem cell transplant recipients receiving oral azoles prophylaxis

Montesinos P; (...); Sanz MA

Article. 10.1038/bmt.2015.181. 2015


Incompatibility of undiluted busulfan injection with a needle-free valve

Cueto-Sola, M; (...); Poveda-Andres, JL

Letter. 10.2146/ajhp140111. 2014


Influence of ABCB1 polymorphisms upon the effectiveness of standard treatment for acute myeloid leukemia: A systematic review and meta-analysis of observational studies

Megías-Vericat JE; (...); Aliño SF

Review. 10.1038/tpj.2014.80. 2015


Influence of Single Nucleotide Polymorphisms in Anthracycline Metabolism Pathway in Standard Induction of Acute Myeloid Leukemia

Eduardo Megias, Juan; (...); Angel Sanz, Miguel

Meeting Abstract. 2015


Inhaled Corticosteroids Do Not Influence the Early Inflammatory Response and Clinical Presentation of Hospitalized Subjects With COPD Exacerbation

Crisafulli E; (...); Torres A

Article. 10.4187/respcare.03036. 2014

  • Open Access.

N. VICTOR JIMENEZ TORRES (1942-2015) IN MEMORIAM

Climente Martí M, Poveda Andrés JL, Culebras J

Biographical-Item. 10.3305/nh.2015.32.4.9704. 2015

  • Open Access.

One-unit versus two-unit cord-blood transplantation.

Sanz J, Sanz GF, Sanz MA

Letter. 2015


Outcome of graft failure after allogeneic stem cell transplant: study of 89 patients

Ferrà C; (...); Ribera JM

Article. 10.3109/10428194.2014.930849. 2015


Outcome of patients with abnl(17p) acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation

Middeke JM; (...); Schetelig J

Article. 10.1182/blood-2013-12-544957. 2014


Passenger lymphocyte syndrome in liver transplant recipients: a description of 12 cases

Romero S; (...); Sanz MÁ

Article. 10.2450/2015.0148-14. 2015


Pharmacogenomics and the treatment of acute myeloid leukemia

Megías-Vericat JE; (...); Aliño SF

Review. 10.2217/pgs-2016-0055. 2016


Positive impact of ABCB1 polymorphisms in overall survival and complete remission in acute myeloid leukemia: a systematic review and meta-analysis

Megías-Vericat JE; (...); Aliño SF

Letter. 10.1038/tpj.2015.79. 2016


Predicting In-Hospital Treatment Failure (<= 7 days) in Patients with COPD Exacerbation Using Antibiotics and Systemic Steroids

Crisafulli E; (...); Menéndez R

Article. 10.3109/15412555.2015.1057276. 2016


Prognostic Impact of Anthracycline Metabolism Gene Polymorphisms in Newly Diagnosed Acute Myeloid Leukemia Adults

Eduardo Megias, Juan; (...); Angel Sanz, Miguel

Article. 2014


Prognostic Impact of Cytarabine Pathway Gene Polymorphisms in Acute Myeloid Leukemia Adults Undergoing Induction Chemotherapy

Eduardo Megias, Juan; (...); Angel Sanz, Miguel

Article. 2014


PROGNOSTIC IMPACT OF TRANSPORTER GENE POLYMORPHISMS IN NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA ADULTS

Megias Vericat, J. E.; (...); Sanz, M. A.

Article. 2015

  • Open Access.

Review of Cutaneous Graft-vs-Host Disease.

Ballester-Sánchez R; (...); Botella-Estrada R

Article. 10.1016/j.ad.2015.10.003. 2016


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


Study on the Linezolid Prescription According to the Approval of Indication in a University Hospital

Pérez-Cebrián M; (...); Llopis-González A

Article. 2015


T Cell-Depleted Related HLA-Mismatched Peripheral Blood Stem Cell Transplantation as Salvage Therapy for Graft Failure after Single Unit Unrelated Donor Umbilical Cord Blood Transplantation

Moscardó F; (...); Sanz GF

Article. 10.1016/j.bbmt.2014.03.024. 2014


The role of bone marrow biopsy and FDG-PET/CT in identifying bone marrow infiltration in the initial diagnosis of high grade non-Hodgkin B-cell lymphoma and Hodgkin lymphoma. accuracy in a multicenter series of 372 patients

Chen-Liang TH; (...); Ortuño FJ

Article. 10.1002/ajh.24044. 2015


The role of phototherapy in cutaneous chronic graft-vs-host disease: a retrospective study and review of the literature.

Ballester-Sánchez R; (...); Botella-Estrada R

Article. 10.1016/j.ad.2015.04.009. 2015


Trans-arterial chemoembolization with doxorubicin-eluting particles versus conventional trans-arterial chemoembolization in unresectable hepatocellular carcinoma: A study of effectiveness, safety and costs.

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

Article. 10.1016/j.rx.2015.01.008. 2015


Transfusion Management and Immunohematologic Complications in Liver Transplantation: Experience of a Single Institution

Solves P; (...); Sanz MÁ

Article. 10.1159/000370260. 2015


Transfusion of ABO non-identical platelets does not influence the clinical outcome of patients undergoing autologous haematopoietic stem cell transplantation

Solves P; (...); Sanz MA

Article. 10.2450/2015.0195-14. 2015


Treatment of invasive fungal disease using anidulafungin alone or in combination for hematologic patients with concomitant hepatic or renal impairment

Montesinos P; (...); Sanz MÁ

Article. 10.1016/j.riam.2014.10.003. 2015


Umbilical cord blood transplantation in adults with advanced hodgkin's disease: high incidence of post-transplant lymphoproliferative disease

Piñana JL; (...); GETH GITMO groups

Article. 10.1111/ejh.12557. 2016


Use of 2 hydroxypropyl-beta-cyclodextrin therapy in two adult Niemann Pick Type C patients

García-Robles AA; (...); Poveda JL

Letter. 10.1016/j.jns.2016.04.048. 2016


Validation of a risk score for post-engraftment invasive fungal disease in 414 adult allogeneic hematopoietic stem cell transplant recipients

Montesinos, P.; (...); Sanz, M. A.

Meeting Abstract. 2016


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