ESTUDIO ABIERTO EN PACIENTES ADOLESCENTES Y ADULTOS CON HEMOFILIA A O B GRAVE (ACTIVIDAD DEL FACTOR DE COAGULACIÓN <1 %) CON O SIN INHIBIDORES PARA COMPARAR EL TRATAMIENTO ESTÁNDAR CON LA PROFILAXIS CON PF-06741086.
Datos básicos
- Protocolo:
- B7841005
- EUDRACT:
- 2018-003660-31
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2020
- Año de finalización:
- 2023
Documentos
- No hay documentos
Participantes
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
2019 SEFH National Survey: service portfolio, care activities, education and research in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11611. 2021
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A post hoc comparative real-world analysis of HEAD-US score for joint health assessment of patients with severe haemophilia A and B in Spain
Alvarez-Roman, Maria Teresa; (...); Kim, Hae Kyung
Article. 10.1111/hae.14924. 2024
Adherence to prophylaxis in adult patients with severe haemophilia A
Bonanad, S; (...); Alvarez, MP
Article. 10.1111/hae.14039. 2020
Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital
Valero García S; (...); Poveda Andrés JL
Article. 10.1177/10781552211038518. 2021
Association of Vitamin K and Non-Vitamin K Oral Anticoagulant Use and Cancer Incidence in Atrial Fibrillation Patients
Iftimi AA; (...); Sanfélix-Gimeno G
Article. 10.1002/cpt.2362. 2021
Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.
Iglesias Gómez R; (...); Poveda Andrés JL
Article. 10.1136/ejhpharm-2021-002741. 2021
Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.
Pérez-Alenda S; (...); Núñez-Cortés R
Article. 10.1111/hae.14988. 2024
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
Fernandez Rivera C; (...); Hernandez D
Article. 10.1111/ctr.14550. 2022
Bladder cancer patients have increased NETosis and impaired DNaseI-mediated NET degradation that can be therapeutically restored in vitro.
Article. 10.3389/fimmu.2023.1171065. 2023
Cerebral calcium embolism.
Asensi Canto, Pedro; (...); Bonanad Boix, Santiago
Article. 10.1002/ccr3.4962. 2022
Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients
Megias-Vericat, JE; (...); Poveda, JL
Article. 10.1016/j.thromres.2021.07.009. 2021
Clinical, pharmacokinetic and economic analysis of the first switch to an extended half-life factor IX (albutrepenonacog alfa, rFIX-FP) in Spain.
Rodríguez López M; (...); Bonanad S
Article. 10.1136/bcr-2019-234142. 2020
Comparative analysis of Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) scores in persons with nonsevere hemophilia A and B reveals a high degree of joint damage in both disease types
Jimenez-Yuste, Victor; (...); Kim, Hae Kyung
Letter. 10.1016/j.rpth.2023.102207. 2023
Comparison of pharmacokinetic estimates using generic and specific population pharmacokinetic models of plasma-derived factor VIII/VWF using WAPPS-Hemo
Megias-Vericat, JE; (...); Poveda, JL
Meeting Abstract. 2020
Comprehensive Screening of Genetic Variants in the Coding Region of F8 in Severe Hemophilia A Reveals a Relationship with Disease Severity in a Colombian Cohort.
Sarmiento Doncel, Samuel; (...); Lopez Guerrero, Jose A
Article. 10.3390/life14081041. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus Statement on Hemostatic Management, Anticoagulation, and Antiplatelet Therapy in Liver Transplantation.
Montalvá E; (...); Colmenero J
Article. 10.1097/TP.0000000000004014. 2022
COSTS OF THE MANAGEMENT OF HEMOPHILIA A WITH INHIBITORS IN SPAIN
Bonanad, S; (...); Gonzalez-Dominguez, A
Meeting Abstract. 2020
Costs of the management of hemophilia A with inhibitors in Spain
Bonanad, S; (...); Gonzalez-Dominguez, A
Article. 10.33393/grhta.2021.2234. 2021
Challenges, questions and opportunities with regard to the new relationship between clinical practice and the haemostasis laboratory: the path towards personalized medicine.
Article. 10.1097/MBC.0000000000001091. 2021
Delving into the clinical impact of NETs in pediatric cancer.
Benavent N; (...); Medina P
Article. 10.1038/s41390-024-03437-4. 2024
Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.
Salinas P; (...); Escaned J
Article. 10.1016/j.carrev.2021.11.015. 2021
Determinants of bleeding before and during immune tolerance in 222 boys with severe hemophilia A and inhibitors >5 BU.
Fischer K; (...); Königs C
Article. 10.1182/bloodadvances.2023011442. 2024
Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.
Megias-Vericat, J E; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2024.109122. 2024
DIAGNOSIS AND MANAGEMENT OF HEMARTHROSIS AND HAEMOPHILIC ARTHROPATHY USING UNIFIED CLINICAL AND ULTRASOUND CRITERIA: PRELIMINARY RESULTS
Chimeno-Hernandez, A; (...); Querol, F
Meeting Abstract. 2021
DIAGNOSIS OF JOINT BLEEDS: PREDICTIVE MODELING BASED ON PATIENT-REPORTED SYMPTOMS
Goldmann, G.; (...); Tiede, A.
Meeting Abstract. 2023
Efecto de la adición de fortificantes y de módulo de proteínas en la osmolalidad de la leche materna donada.
Torres Martínez E; (...); Vento M
Article. 10.1016/j.anpedi.2020.03.009. 2020
Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment
Palanques-Pastor T; (...); Poveda Andrés JL
Article. 10.1159/000517813. 2021
Effectiveness of progressive moderate-vigorous intensity elastic resistance training on quality of life and perceived functional abilities in people with haemophilia: secondary analysis of a randomized controlled trial.
Cruz-Montecinos C; (...); Calatayud J
Article. 10.1111/ejh.13900. 2022
Effects of a non-pharmacological approach for chronic pain management in patients with haemophilia: efficacy of cognitive-behavioural therapy associated with physiotherapy.
García-Dasí M; (...); Bonanad S
Article. 10.1111/hae.14284. 2021
EFFECTS OF MULTIMODAL EXERCISES PROGRAM ON BALANCE, FUNCTIONALITY, RISK OF FALLS AND STRENGTH IN PEOPLE WITH HAEMOPHILIA
Chimeno-Hernandez, A.; (...); Querol, F.
Article. 2022
Efficacy and safety evaluation of Fanhdi ® , a plasma-derived factor VIII/ von Willebrand factor concentrate, in Von Willebrand's disease patients undergoing surgery or invasive procedures: A prospective clinical study.
Jimenez-Yuste, Victor; (...); Paez, Antonio
Letter. 10.1111/hae.14453. 2022
EFFICACY AND SAFETY OF EPTACOG BETA (RECOMBINANT HUMAN FVIIA) ACCORDING TO AGE IN PERSONS WITH HAEMOPHILIA A/B WITH INHIBITORS UNDERGOING SURGICAL PROCEDURES
Miesbach, W.; (...); Mahlangu, J.
Meeting Abstract. 2023
Emicizumab-induced photosensitivity.
Asensi Canto, Pedro; (...); Haya Guaita, Saturnino
Article. 10.1055/s-0042-1749092. 2022
EPTACOG BETA EFFICACY AT 24 HOURS POSTINFUSION FOR MILD OR MODERATE BLEEDS IN INDIVIDUALS WITH HEMOPHILIA A OR B AND INHIBITORS
Boggio, Lisa; (...); Escobar, Miguel
Meeting Abstract. 2023
Feasibility, safety and muscle activity during flywheel vs traditional strength training in adult patients with severe haemophilia.
Calatayud J; (...); Casaña J
Article. 10.1111/hae.14170. 2020
FEIBA GLOBAL OUTCOME (FEIBA GO) STUDY: REAL-WORLD DATA IN PATIENTS WITH CONGENITAL HEMOPHILIA AND INHIBITORS
Hermans, C; (...); Windyga, J
Meeting Abstract. 2021
Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report
Fernandez-Sanchez, M; (...); Poveda-Andres, JL
Article. 10.1002/bdr2.1942. 2021
Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.
de la Rubia J; (...); Bonanad, Santiago
Article. 10.1016/j.jgo.2022.10.016. 2022
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
Haemophilic arthropathy: basic protocols for clinical examination and imaging.
Querol, F.; (...); Perez-Alenda, S.
Article. 10.1097/MBC.0000000000001215. 2023
Haemotrack: Musculoskeletal management in haemophilia with physiotherapist-driven digital solutions
Perez-Alenda, Sofia; (...); Aguilar-Rodriguez, Marta
Meeting Abstract. 2024
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
Hospitalization budget impact during the COVID-19 pandemic in Spain.
Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.
Article. 10.1186/s13561-021-00340-0. 2021
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Impact of combinations of single-nucleotide polymorphisms of anthracycline transporter genes upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia.
Megías-Vericat JE; (...); Montesinos P
Article. 10.1080/10428194.2020.1839650. 2020
IMPACT OF INITIATION OF PROPHYLAXIS, SYNOVITIS AND FUNCTIONALITY ON JOINT HEALTH IN PATIENTS WITH HEMOPHILIA
Chimeno, A.; (...); Bonanad Boix, S.
Meeting Abstract. 2023
Increase of Neutrophil Activation Markers in Venous Thrombosis-Contribution of Circulating Activated Protein C
Martos L; (...); Medina P
Article. 10.3390/ijms21165651. 2020
Influence of polymorphisms in anthracyclines metabolism genes in the standard induction chemotherapy of acute myeloid leukemia.
Megías-Vericat JE; (...); Montesinos P
Article. 10.1097/FPC.0000000000000431. 2021
Management of acquired hemophilia A: results from the Spanish registry.
Mingot-Castellano ME; (...); Marco P
Article. 10.1182/bloodadvances.2021004626. 2021
Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.
Megías-Vericat JE; (...); Poveda-Andrés JL
Article. 2021
Management of Urgent Bleeding in Patients with Hemophilia A: Focus on the Use of Emicizumab.
Jiménez-Yuste V; (...); Rodríguez-López M
Article. 10.1055/s-0044-1785525. 2024
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A
Bonanad, S; (...); Santos, S
Article. 10.1007/s12325-021-01853-0. 2021
Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.
Rodríguez MA; (...); Chimeno-Hernández A
Article. 10.1016/j.thromres.2024.109181. 2024
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
Moderate haemophilia A: Recommendations from a Spanish panel of experts.
Álvarez Román MT; (...); López-Jaime FJ
Article. 10.1111/hae.15110. 2024
Monitoring coagulation factors during surgery. A systematic review
Eduardo Megias-Vericat, Juan; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11766. 2021
Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).
Valero-García S; (...); Delgado-Sánchez O
Article. 10.7399/fh.11655. 2021
MONITORING OF THE JOINT HEALTH OF PATIENTS WITH HEMOPHILIA IN SPAIN. INITIAL ANALYSIS OF THE JOINT US PROJECT
Alvarez-Roman, MT; (...); Querol, F
Meeting Abstract. 2021
Multimodal exercises program to improve balance in patients with haemophilia: preliminary results
Chimeno-Hernandez, A; (...); Quero, F
Meeting Abstract. 2021
Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments
Gomez-Cebrian, N; (...); Pineda-Lucena, A
Review. 10.3390/cancers13184544. 2021
National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)
Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel
Correction. 10.7399/fh.11740. 2021
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
Neutrophil extracellular traps (NETs) in patients with STEMI. Association with percutaneous coronary intervention and antithrombotic treatments.
Ferre-Vallverdu, Mari; (...); Moscardo, Antonio
Article. 10.1016/j.thromres.2022.03.002. 2022
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project
Morillo-Verdugo, R; (...); Diaz-Olmo, J
Article. 10.7399/fh.11719. 2021
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.
Morillo-Verdugo R; (...); Díaz-Olmo J
Article. 2021
Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Pegcetacoplan: Real Life Experience
Vallejo, Carlos; (...); Vara, Miriam
Meeting Abstract. 10.1182/blood-2023-185570. 2023
Pharmacokinetic and clinical improvements after PK-guided switch from standard half-life to extended half-life factor VIII products.
Megias-Vericat, J. E.; (...); Poveda Andres, J. L.
Article. 10.1016/j.thromres.2022.06.001. 2022
Pharmacometabolomics by NMR in Oncology: A Systematic Review.
Gómez-Cebrián N; (...); Pineda-Lucena A
Article. 10.3390/ph14101015. 2021
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
PK-guided switch from standard half-life to extended half-life factor VIII products
Megias-Vericat, JE; (...); Iorio, Alfonso
Meeting Abstract. 2020
Preparation and administration of insulin infusions in neonatology: A national survey.
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Article. 10.1016/j.anpede.2020.06.015. 2021
Proactive therapeutic drug monitoring and pharmacogenetic analysis in inflammatory bowel disease: A systematic review
Ballesta-Lopez, Octavio; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11780. 2021
Quality of electronic treatment records and adherence to prophylaxis in haemophilia and von Willebrand disease: Systematic assessments from an electronic diary.
Tiede A; (...); Oldenburg J
Article. 10.1111/hae.14178. 2020
Real-world analysis of the PK-guided switch from standard half-life factor VIII to efmoroctocog alfa.
Megias-Vericata, J. E.; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2023.11.023. 2023
Real-world data in patients with congenital hemophilia and inhibitors: final data from the FEIBA Global Outcome (FEIBA GO) study.
Ettingshausen CE; (...); Windyga J
Article. 10.1177/20406207231184323. 2023
Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia.
Calatayud J; (...); Casaña J
Article. 10.1093/ptj/pzaa106. 2020
SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11565. 2020
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Spanish Society of Hematology and Hemotherapy expert consensus opinion for SARS-CoV-2 vaccination in onco-hematological patients.
Pinana, JL; (...); Bosch F
Article. 10.1080/10428194.2021.1992619. 2021
Suitability and readiness assessment of organizational resources for the implementation of gene therapy in hemophilia in Spain and Portugal: A survey-based study.
Villas JMC; (...); Álvarez-Román MT
Letter. 10.1016/j.thromres.2024.109180. 2024
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
The factor VIII treatment history of non-severe hemophilia A: COMMENT. Joint damage in adult patients with mild or moderate hemophilia A evaluated with the HEAD-US system
Roman, MTA; (...); Mosteirin, NF
Letter. 10.1111/jth.15475. 2021
The ISTH bleeding assessment tool as predictor of bleeding events in inherited platelet disorders: Communication from the ISTH SSC Subcommittee on Platelet Physiology
Gresele, P; (...); BAT-VAL Study Investigators
Article. 10.1111/jth.15263. 2021
The Limitations and Unmet Needs of the Five Cornerstones to Guarantee Lifelong Optimization of Prophylaxis in Hemophilia Patients.
Nunez, Ramiro; (...); Jimenez-Yuste, Victor
Article. 10.1055/s-0042-1757745. 2022
The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors.
Escobar, M; (...); Kessler, C
Article. 10.1111/hae.14419. 2021
Thromboembolic hazard in hereditary hemorrhagic telangiectasia.
Asensi Canto, Pedro; (...); Bonanad Boix, Santiago
Article. 10.1002/jha2.471. 2022
Thrombotic risk and features of patients with inferior vena cava agenesis: a multicentre, retrospective, observational study.
Bravo-Perez, Carlos; (...); Corral, Javier
Article. 10.1016/S2352-3026(24)00138-8. 2024
Towards a symbiotic relationship between big data, artificial intelligence, and hospital pharmacy
Del Rio-Bermudez, C; (...); Poveda, JL
Editorial Material. 10.1186/s40545-020-00276-6. 2020
Type 2N VWD: Conclusions from the Spanish PCM-EVW-ES project
Perez-Rodriguez, Almudena; (...); Lopez-Fernandez, Maria Fernanda
Article. 10.1111/hae.14405. 2021
Ultrasound evaluation of joint damage and disease activity in adult patients with severe haemophilia A using the HEAD-US system.
Jiménez-Yuste V; (...); Kim HK
Article. 10.1111/hae.14280. 2021