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  3. ENSAYO ALEATORIZADO, CRUZADO, ABIERTO, EN DOS PARTES , PARA EVALUAR LA FARMACOCINETICA, LA EFICACIA Y EL PERFIL DE SEGURIDAD DE FVIII RECOMBINANTE LIBRE DE PROTEINA PLASMATICA, FORMULADO CON SACAROSA (BAY 81-8973) CON HEMOFILIA-A SEVERA , PREVIAMENTE TRAT ADOS CON TERAPIA PROFILACTICA.

ENSAYO ALEATORIZADO, CRUZADO, ABIERTO, EN DOS PARTES , PARA EVALUAR LA FARMACOCINETICA, LA EFICACIA Y EL PERFIL DE SEGURIDAD DE FVIII RECOMBINANTE LIBRE DE PROTEINA PLASMATICA, FORMULADO CON SACAROSA (BAY 81-8973) CON HEMOFILIA-A SEVERA , PREVIAMENTE TRAT ADOS CON TERAPIA PROFILACTICA.

Datos básicos

Código:
BAY81-8973/12954
Protocolo:
BAY81-8973/12954
EUDRACT:
2009-012149-43
NCT:
Centro:
Dotación:
Año de incio:
Año de finalización:
ENSAYO CLÍNICO

Documentos

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Participantes

Grupos

Financiadores - Promotores

BAYER HEALTHCARE

Resultados del Ensayo Clínico

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


Challenges, questions and opportunities with regard to the new relationship between clinical practice and the haemostasis laboratory: the path towards personalized medicine.

Cid AR

Article. 10.1097/MBC.0000000000001091. 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


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


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


Emicizumab-induced photosensitivity.

Asensi Canto, Pedro; (...); Haya Guaita, Saturnino

Article. 10.1055/s-0042-1749092. 2022


FEIBA GLOBAL OUTCOME (FEIBA GO) STUDY: REAL-WORLD DATA IN PATIENTS WITH CONGENITAL HEMOPHILIA AND INHIBITORS

Hermans, C; (...); Windyga, J

Meeting Abstract. 2021


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


IMPACT OF INITIATION OF PROPHYLAXIS, SYNOVITIS AND FUNCTIONALITY ON JOINT HEALTH IN PATIENTS WITH HEMOPHILIA

Chimeno, A.; (...); Bonanad Boix, S.

Meeting Abstract. 2023


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


Less common hemorrhagic coagulopathies in women.

Cid AR

Article. 10.1097/MBC.0000000000000990. 2020


Management of acquired hemophilia A: results from the Spanish registry.

Mingot-Castellano ME; (...); Marco P

Article. 10.1182/bloodadvances.2021004626. 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


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


Musculoskeletal ultrasound in hemophilia: Results and recommendations from a global survey and consensus meeting.

Bakeer, Nihal; (...); Blanchette, Victor S

Article. 10.1002/rth2.12531. 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


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


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


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


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


Campos de estudio

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