ESTUDIO ABIERTO, MULTICÉNTRICO PARA EVALUAR LA FARMACOCINÉTICA, LA SEGURIDAD Y LA EFICACIA DE OMBITASVIR (OBV), PARITAPREVIR (PTV), RITONAVIR (RTV), CON O SIN DASABUVIR (DSV) Y CON O SIN RIBAVIRINA (RBV) EN PACIENTES PEDIÁTRICOS CON INFECCIÓN CRÓNICA POR EL VIRUS DE LA HEPATITIS C (VHC) GENOTIPO 1 O 4 (ZIRCON).

Dades bàsiques

Protocol:
M14-748
EURDRACT:
2015-000111-41
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2016
Any de finalització:
2019
ENSAYO CLÍNICO INTERNACIONAL

Documents

  • No hi ha documents

Participants

Grups d'Investigació

Finançadors - Promotors

ABBVIE DEUTSCHLAND GMBH & CO. KG

Resultats de l'Assaig Clínic


A first approach for an evidence-based in vitro digestion method to adjust pancreatic enzyme replacement therapy in cystic fibrosis

Calvo-Lerma, J; (...); Andres, A

Article. 10.1371/journal.pone.0212459. 2019

  • Open Access.

A MULTI-STAKEHOLDER MULTICRITERIA DECISION ANALYSIS IN DIABETIC MACULAR EDEMA. MULTIDEX-EMD STUDY.

Casado, MA; (...); Grp MULTIDEX-EMD

Meeting Abstract. 10.1016/j.jval.2018.09.2545. 2018

  • 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


Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice

Werkstetter, KJ; (...); ProCeDE study group

Article. 10.1053/j.gastro.2017.06.002. 2017

  • Open Access.

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


Albumin dialysis with MARS for the treatment of anabolic steroid-induced cholestasis

Diaz, FC; (...); Prieto, M

Article. 10.5604/16652681.1222114. 2016


An international consensus report on a new algorithm for the management of infant diarrhoea

Lo Vecchio, A; (...); Guarino, A

Article. 10.1111/apa.13432. 2016


Analysing criteria for price and reimbursement of orphan drugs in Spain.

Badia, X; (...); Tort, M

Article. 10.7399/fh.11147. 2019

  • Open Access.

Anticuerpos antitransglutaminasa no relacionados con la ingesta de gluten.

Garcia-Peris, M; (...); Ribes Koninckx C

Abstract of Published Item. 10.1016/j.anpedi.2018.01.013. 2018

  • Open Access.

Anti-gliadin antibodies in breast milk from celiac mothers on a gluten-free diet

Roca, Maria; (...); PREVENT CD Study Group

Article. 10.1007/s00394-017-1476-1. 2018


Antimicrobial stewardship programme implementation in a medical ward

Ruiz, J; (...); Poveda, JL

Article. 2018


Antimicrobial stewardship programme in critical care medicine: A prospective interventional study

Ruiz, J; (...); Catellanos, A

Article. 10.1016/j.medin.2017.07.002. 2018


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.

Bayesian pharmacokinetic individualization of prophylaxis with recombinant factor VIII in severe or moderate hemophilia A

Megias-Vericat, JE; (...); Bonanad, S

Meeting Abstract. 2018


Bayesian pharmacokinetic-guided prophylaxis with recombinant factor VIII in severe or moderate haemophilia A

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2018.12.027. 2019


BK Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation in the Pediatric Population

Perez-Huertas, P; (...); Poveda-Andres, JL

Article. 10.1177/1043454216631952. 2017


Breakthrough invasive fungal disease in high-risk hematologic malignancies in children: a single-center experience

Garcia-Robles, AA; (...); Fernandez-Navarro, JM

Meeting Abstract. 2017


Case report of a trichohepatoenteric syndrome due to heterozygous compound of novel mutations in ttc37 gen

Polo, B.; (...); Cervera, J.

Meeting Abstract. 2019


Clinical and molecular characterization of Wilson's disease in the Valencian Region

Sanchez-Monteagudo, A; (...); Espinos, C

Meeting Abstract. 2018


Clinical pharmacy services: from cost-effectiveness analysis to a productivity indicators model

Nogueras, A; (...); Calleja, MA

Letter. 10.1136/ejhpharm-2019-001905. 2019

  • Open Access.

Clinical validation of an evidence-based method to adjust Pancreatic Enzyme Replacement Therapy through a prospective interventional study in paediatric patients with Cystic Fibrosis

Calvo-Lerma, J; (...); MyCyFAPP Project

Article. 10.1371/journal.pone.0213216. 2019

  • Open Access.

Colestasis hepática infantil: presentación de un caso inusual de histiocitosis de células de Langerhans asociado a fibrosis avanzada.

Martínez I Cózar V; (...); Pérez Rojas J

Article. 10.1016/j.patol.2019.03.004. 2022


Collaborative model of home delivery program in haemophilia through an association of patients

Megias-Vericat, JE; (...); Bonanad, S

Meeting Abstract. 2018


Cost-effectiveness analysis of implementing an antimicrobial stewardship program in critical care units

Ruiz-Ramos, J; (...); Ramirez, P

Article. 10.1080/13696998.2017.1311903. 2017


COST-EFFECTIVENESS OF CLADRIBINE TABLETS AND FINGOLIMOD IN THE TREATMENT OF REMITTING MULTIPLE SCLEROSIS WITH HIGH DISEASE ACTIVITY IN SPAIN

Trillo, JL; (...); Torres, C

Meeting Abstract. 10.1016/j.jval.2018.09.2029. 2018

  • Open Access.

Cross-sectional comparative study of pharmacokinetics and efficacy between sucrose-formulated recombinant factor VIII (Kogenate (R)) and BAY 81-8973 (KovaltryA (R)) in patients with severe or moderate haemophilia A in prophylaxis

Megias-Vericat, JE; (...); Poveda, JL

Letter. 10.1111/hae.13733. 2019


Daunorubicin and cytarabine for certain types of poor-prognosis acute myeloid leukemia: a systematic literature review

Megias-Vericat, JE; (...); Montesinos, P

Review. 10.1080/17512433.2019.1573668. 2019


Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project

Blade, J; (...); Lizan, L

Article. 10.1136/bmjopen-2017-018850. 2018

  • Open Access.

Detection and quantification of gluten immunogenic peptides in feces of infants and their relationship with diet

Roca, M; (...); Ribes-Koninckx, C

Article. 10.17235/reed.2018.5549/2018. 2019

  • Open Access.

Development and validation of two food frequency questionnaires to assess gluten intake in children up to 36 months of age

Crespo Escobar P; (...); Ribes Koninckx C

Article. 10.3305/nh.2015.32.5.9655. 2015

  • Open Access.

Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study

Vandenplas Y; (...); BITSS Study Group

Article. 10.1136/bmjopen-2016-014620. 2017

  • Open Access.

Differences in the macronutrient and dietary fibre profile of gluten-free products as compared to their gluten-containing counterparts

Calvo-Lerma, J; (...); Ribes-Koninckx, C

Article. 10.1038/s41430-018-0385-6. 2019


Early experience with compassionate use of 2 hydroxypropyl-beta-cyclodextrin for Niemann-Pick type C disease: review of initial published cases

Megias-Vericat, JE; (...); Poveda, JL

Review. 10.1007/s10072-017-2833-9. 2017


Economic impact of optimising antiretroviral treatment in human immunodeficiency virus-infected adults with suppressed viral load in Spain, by implementing the grade A-1 evidence recommendations of the 2015 GESIDA/National AIDS Plan

Ribera, E; (...); Hernandez-Novoa, B

Article. 10.1016/j.eimc.2016.11.015. 2018


eLearning of pharmacokinetic monitoring in hemophilia with application in the clinical practice

Bonanad, S; (...); Megias-Vericat, JE

Meeting Abstract. 2018


ESPGHAN 2012 Guidelines for Coeliac Disease Diagnosis: Validation Through a Retrospective Spanish Multicentric Study

Donat E; (...); Ribes-Koninckx C

Article. 10.1097/MPG.0000000000000870. 2016


Experience of Home Delivery Program in Haemophilia Through an Association of Patients

Megias Vericat, J. E.; (...); Bonanad Boix, S.

Meeting Abstract. 2017


Exploratory analysis for the implementation of antineoplastic logarithmic dose banding

Albert-Mari, A; (...); Poveda-Andres, JL

Article. 10.1007/s11096-018-0714-9. 2018


Fecal Calprotectin and Eosinophil-derived Neurotoxin in Healthy Children Between 0 and 12 Years

Roca, Maria; (...); Ribes-Koninckx, Carmen

Article. 10.1097/MPG.0000000000001542. 2017


Fecal Calprotectin Pretreatment and Induction Infliximab Levels for Prediction of Primary Nonresponse to Infliximab Therapy in Crohn's Disease

Beltran, B; (...); Nos, P

Article. 10.1159/000492626. 2019


Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients

Comino, I; (...); Sousa, C

Article. 10.1038/ajg.2016.439. 2016

  • Open Access.

Functional gastro-intestinal disorder algorithms focus on early recognition, parental reassurance and nutritional strategies

Vandenplas, Y; (...); Wilschanski, M

Review. 10.1111/apa.13270. 2016


Genetics in idiopathic pancreatitis and acute recurrent pancreatitis

Martinez-Barona, S, Ribes-Koninckx, C

Letter. 10.17235/reed.2017.4632/2016. 2017

  • Open Access.

Gluten Introduction and the Risk of Coeliac Disease: A Position Paper by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition

Szajewska, H; (...); Troncone, R

Article. 10.1097/MPG.0000000000001105. 2016


Guideline for wireless capsule endoscopy in children and adolescents: A consensus document by the SEGHNP (Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition) and the SEPD (Spanish Society for Digestive Diseases)

Arguelles-Arias, F; (...); Ribes-Koninckx, C

Article. 2015

  • Open Access.

Haemodialysis significantly reduces serum levetiracetam levels inducing epileptic seizures: Case report

Company-Albir, MJ; (...); Poveda, JL

Article. 10.1111/jcpt.12568. 2017


Hazardous drugs levels in compounding area surfaces of Hospital Pharmacies Services: multicentric study

Valero-Garcia, S; (...); Spanish Hosp Pharmacy Units

Article. 10.7399/fh.10935. 2018

  • Open Access.

Hazardous drugs: new challenges, new opportunities.

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

Article. 10.7399/fh.2016.40.2.10462. 2016

  • Open Access.

Impact of ABC single nucleotide polymorphisms upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia

Megias-Vericat, JE; (...); Aliño SF

Article. 10.1080/10428194.2016.1231405. 2017


Impact of adherence on subcutaneous interferon beta-1a effectiveness administered by Rebismart (R) in patients with multiple sclerosis

Edo Solsona MD; (...); Poveda Andrés JL

Article. 10.2147/PPA.S127508. 2017

  • Open Access.

IMPACT OF ADHERENCE ON SUBCUTANEOUS INTERFERON BETA-1A EFFECTIVENESS ADMINISTERED BY REBISMART (R) IN PATIENTS WITH MULTIPLE SCLEROSIS

Edo-Solsona, M.; (...); Poveda-Andres, J.

Meeting Abstract. 10.1016/j.jval.2016.09.512. 2016

  • Open Access.

Impact of an antimicrobial stewardship program on critical haematological patients.

Ruiz-Ramos, J; (...); Ramirez, P

Article. 10.7399/fh.2017.41.4.10709. 2017

  • Open Access.

Impact of NADPH oxidase functional polymorphisms in acute myeloid leukemia induction chemotherapy

Megias-Vericat, JE; (...); Aliño SF

Article. 10.1038/tpj.2017.19. 2018


Impact of novel polymorphisms related to cytotoxicity of cytarabine in the induction treatment of acute myeloid leukemia

Megias-Vericat, JE; (...); Aliño SF

Article. 10.1097/FPC.0000000000000286. 2017


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

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

Meeting Abstract. 2015


Implication of Haemodiafiltration Flow Rate on Amikacin Pharmacokinetic Parameters in Critically Ill Patients

Ruiz-Ramos, J; (...); Ramirez, P

Article. 10.1159/000478969. 2018


Increased prevalence of pathogenic bacteria in the gut microbiota of infants at risk of developing celiac disease: The PROFICEL study

Olivares, M; (...); Sanz, Y

Article. 10.1080/19490976.2018.1451276. 2018

  • Open Access.

Individualization of prophylaxis with recombinant factor VIII in severe or moderate hemophilia A

Vericat, JEM; (...); Bonanad, S

Meeting Abstract. 2018


Individualized Prophylactic Treatment with Recombinant Factor VIII in Severe or Moderate Haemophilia a Patients. Association Between Pharmacokinetic Parameters and Clinical Variables

Megias-Vericat, Juan Eduardo; (...); Bonanad, Santiago

Meeting Abstract. 10.1182/blood.V128.22.3802.3802. 2016


Influence of concomitant immunomodulators during maintenance therapy with Adalimumab in inflammatory bowel disease: looking for the ideal patient to use monotherapy

Bastida, G; (...); Nos, P

Meeting Abstract. 10.1093/ecco-jcc/jjy222.581. 2019

  • Open Access.

Influence of cytarabine metabolic pathway polymorphisms in acute myeloid leukemia induction treatment

Megias-Vericat, JE; (...); Aliño SF

Article. 10.1080/10428194.2017.1323267. 2017


Influence of pharmacokinetic/pharmacodynamic ratio on vancomycin treatment response in paediatric patients with Staphylococcus aureus bacteremia.

Ruiz J; (...); Poveda JL

Article. 10.23736/S0026-4946.18.04978-2. 2018


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


Innovative approach for self-management and social welfare of children with cystic fibrosis in Europe: development, validation and implementation of an mHealth tool (MyCyFAPP)

Calvo-Lerma J; (...); MyCyFAPP

Article. 10.1136/bmjopen-2016-014931. 2017

  • Open Access.

Interdisciplinary recommendations document to improve adherence in patients with chronic inflammatory diseases: Adhing recommendations.

Bermejo San José F; (...); Sanromán-Álvarez L

Article. 10.7399/fh.2016.40.5.10180. 2016

  • Open Access.

Intestinal anti-transglutaminase 2 immunoglobulin A deposits in children at risk for coeliac disease (CD): data from the PreventCD study

Borrelli, M.; (...); Auricchio, R.

Article. 10.1111/cei.13078. 2018

  • Open Access.

Investigating the early metabolic fingerprint of celiac disease - a prospective approach

Kirchberg, FF; (...); Hellmuth, C

Article. 10.1016/j.jaut.2016.05.006. 2016


La introduccion del gluten en la dieta del lactante. Recomendaciones de un grupo de expertos.

Ribes Koninckx C; (...); Polanco Allue I

Article. 10.1016/j.anpedi.2015.03.009. 2015


Monitoring the quality of the hospital pharmacoterapeutic process by sentinel patient program.

Fernandez-Megia, MJ; (...); Poveda Andrés JL

Article. 10.7399/fh.10793. 2018

  • Open Access.

No Need for Routine Endoscopy in Children With Celiac Disease on a Gluten-free Diet

Koletzko, S; (...); Husby, S

Editorial Material. 10.1097/MPG.0000000000001628. 2017


Non-IgE-mediated cow's milk allergy: Consensus document of the Spanish Society of Paediatric Gastroenterology, Hepatology, and Nutrition (SEGHNP), the Spanish Association of Paediatric Primary Care (AEPAP), the Spanish Society of Extra-hospital Paediatrics and Primary Health Care (SEPEAP), and the Spanish Society of Paediatric ClinicaL Immunology, Allergy, and Asthma (SEICAP)

Jaime, BE; (...); Koninckx, CR

Article. 10.1016/j.anpedi.2018.11.007. 2019

  • Open Access.

Nutritional status, nutrient intake and use of enzyme supplements in paediatric patients with Cystic Fibrosis; a European multicentre study with reference to current guidelines

Calvo-Leima, J; (...); MyCyFAPP Project

Article. 10.1016/j.jcf.2017.03.005. 2017

  • Open Access.

Online course of pharmacokinetic monitoring in hemophilia with application in the clinical practice

Bonanad, S; (...); Poveda, JL

Meeting Abstract. 2018


Optimisation of children z-score calculation based on new statistical techniques

Martinez-Millana, A; (...); Ribes-Koninckx, C

Article. 10.1371/journal.pone.0208362. 2018

  • Open Access.

Pancreatic enzyme replacement therapy in cystic fibrosis: dose, variability and coefficient of fat absorption

Calvo-Lerma, J; (...); Ribes-Koninckx, C

Article. 10.17235/reed.2017.4951/2017. 2017

  • Open Access.

Pharmacogenetics of Metabolic Genes of Anthracyclines in Acute Myeloid Leukemia

Megias-Vericat, JE; (...); Montesinos, P

Review. 10.2174/1389200218666171101124931. 2018


Pharmacogenomics and the treatment of acute myeloid leukemia

Megías-Vericat JE; (...); Aliño SF

Review. 10.2217/pgs-2016-0055. 2016


Pharmacotherapy follow-up of patients under treatment with biologic agents for chronic inflammatory systemic conditions: an agreement among hospital pharmacists for the standardized collection of a minimum set of data.

Calleja Hernández MÁ; (...); Aragon, B

Article. 10.7399/fh.2017.41.1.10463. 2017

  • Open Access.

Physical Activity In Haemophilia: Hemorrhagic Risk And Factor Levels (myPKFiT)

Querol-Fuentes, F; (...); Bonanad, S

Meeting Abstract. 2017


Pilot evaluation of home delivery programme in haemophilia

Megias-Vericat, JE; (...); Poveda-Andres, JL

Article. 10.1111/jcpt.12718. 2018


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


Pre and post intervention study of antiblastic drugs contamination surface levels at a Pharmacy Department Compounding Area using a closed system drug transfer device and a decontamination process

Valero, S; (...); Poveda, JL

Article. 10.1016/j.yrtph.2018.03.001. 2018


PRELIMINAR STUDY OF THERAPY ADHERENCE CONTROLLED BY PRESCRIPTION OF MEDICATION AND SELF-PERCEPTION ADHERENCE OF INFLAMMATORY CHRONIC DISEASE PATIENTS

Garcia, EG; (...); Ivorra, JAR

Meeting Abstract. 10.1136/annrheumdis-2019-eular.5937. 2019

  • Open Access.

Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet

Comino, I; (...); Sousa, C

Article. 10.1111/apt.15277. 2019

  • Open Access.

Prostaglandin Injection After Arterial Compromise Related to Hyaluronic Acid Filler

Megias-Vericat, JE; (...); Poveda, JL

Letter. 10.1097/DSS.0000000000001046. 2017


Protocol for the validation of sensitivity and specificity of the Cow's Milk-related Symptom Score (CoMiSS) against open food challenge in a single-blinded, prospective, multicentre trial in infants

Vandenplas, Y; (...); Chinese CoMiSS Investigator Team

Article. 10.1136/bmjopen-2017-019968. 2018

  • Open Access.

Quantification of physical activity in adult patients with haemophilic arthropathy in prophylaxis treatment using a fitness tracker

Perez-Alenda, S; (...); Querol, F

Letter. 10.1111/hae.13388. 2018


Reduction in alert fatigue in an assisted electronic prescribing system, through the Lean Six Sigma methodology.

Cuéllar Monreal MJ; (...); Poveda Andrés JL

Article. 10.7399/fh.2017.41.1.10434. 2017

  • Open Access.

Role of Polyethylene Glycol in the Treatment of Functional Constipation in Children

Koppen IJN; (...); Benninga, MA

Article. 10.1097/MPG.0000000000001704. 2017


Salvage therapy with topical posaconazole in lung transplant recipients with invasive Scedosporium infection.

Sole, A; (...); Peman, J

Article. 10.1111/ajt.14580. 2018

  • Open Access.

Serum Adalimumab Levels Predict Successful Remission and Safe Deintensification in Inflammatory Bowel Disease Patients in Clinical Practice

Aguas Peris M; (...); Nos, P

Article. 10.1097/MIB.0000000000001182. 2017

  • Open Access.

Serum adalimumab levels predict successful remission and safe de-intensification in inflammatory bowel disease patients in clinical practice

Aguas, M; (...); Nos, P

Meeting Abstract. 2017


Ten years of follow-up of the Spanish cohort of the European PreventCD study: the lessons learned

Crespo-Escobar, P; (...); Ribes-Koninckx, C

Article. 10.17235/reed.2018.5324/2017. 2018

  • Open Access.

The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability

Huysentruyt, K; (...); BITSS Working Grp

Article. 10.1097/MPG.0000000000002153. 2019

  • Open Access.

The Cow Milk Symptom Score (CoMiSS (TM)) in presumed healthy infants

Vandenplas, Y; (...); Huysentruyt, K

Article. 10.1371/journal.pone.0200603. 2018

  • Open Access.

The Potential of Self-Management mHealth for Pediatric Cystic Fibrosis: Mixed-Methods Study for Health Care and App Assessment

Martinez-Millana, A; (...); Traver, V

Article. 10.2196/13362. 2019

  • Open Access.

The role of gluten consumption at an early age in celiac disease development: a further analysis of the prospective PreventCD cohort study

Crespo-Escobar, P; (...); Ribes-Koninckx, C

Article. 10.3945/ajcn.116.144352. 2017

  • Open Access.

The view of experts on initiatives to be undertaken to promote equity in the access to orphan drugs and specialised care for rare diseases in Spain: A Delphi consensus

Torrent-Farnell, J; (...); Lizan, L

Article. 10.1016/j.healthpol.2018.03.002. 2018


Update on lysosomal acid lipase deficiency: Diagnosis, treatment and patient management.

Camarena C; (...); Ros E

Article. 10.1016/j.medcli.2016.12.044. 2017


Use and handling safety of Mini-Spike 2 (R) chemo and puresite for safe chemotherapy compounding in a hospital pharmacy

Garcia, SV; (...); Andres, JLP

Article. 10.1016/j.yrtph.2018.10.002. 2018


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


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