- Inicio
- Proyectos y Estudios
- Estudio en fase III, aleatorizado, doble ciego, controlado con placebo, para evaluar el efecto de resmetirom sobre los resultados relacionados con el hígado en pacientes con esteatohepatitis no alcohólica (EHNA) bien compensada (Child-Pugh A) (RESULTADOS DE MAESTRO-NASH).
Estudio en fase III, aleatorizado, doble ciego, controlado con placebo, para evaluar el efecto de resmetirom sobre los resultados relacionados con el hígado en pacientes con esteatohepatitis no alcohólica (EHNA) bien compensada (Child-Pugh A) (RESULTADOS DE MAESTRO-NASH).
Datos básicos
- Código:
- MGL-3196-19
- Protocolo:
- MGL-3196-19
- EUDRACT:
- 2022-002279-13
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
- 2024
Objetivos del proyecto
Objetivo Principal: • Determinar el efecto de la administración por vía oral, aleatorizada y una vez al día de 80 mg de resmetirom frente al placebo correspondiente sobre los pacientes, medida por el tiempo transcurrido hasta la aparición de un primer acontecimiento adjudicado del criterio de valoración clínico compuesto, definido como cualquiera de los siguientes: mortalidad por cualquier causa, trasplante de hígado, y acontecimientos hepáticos significativos, incluidos acontecimientos de descompensación hepática (ascitis, encefalopatía hepática o hemorragia gastroesofágica por rotura de varices) y aumento confirmado de la puntuación del Modelo de enfermedad hepática en fase terminal (Model for End-stage Liver Disease, MELD) de <12 a =15. Objetivos Secundarios: Objetivos secundarios clave: Determinar el efecto de la administración por vía oral, aleatorizada y una vez al día de 80 mg de resmetirom frente al placebo correspondiente sobre: 1.Cambio porcentual con respecto al inicio del estudio hasta la semana 28 en los niveles de colesterol de lipoproteínas de baja densidad (c-LDL). 2.Cambio porcentual con respecto al inicio del estudio hasta la semana 52 en la fracción de grasa hepática determinado mediante imágenes obtenidas por resonancia magnética de la fracción de grasa por densidad protónica (FGDP-RM) en pacientes con un valor inicial de este parámetro =8 %.
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
In vitro personalised model based on induced pluripotent stem cells for studying idiosyncratic hepatotoxicity
Pelecha, M.; (...); Tolosa, L.
Meeting Abstract. 10.1016/j.toxlet.2024.07.291. 2024
A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.
Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose
Article. 10.3390/ijms25042112. 2024
Adaptation and validation of an abbreviated version of the SIPAT integrated psychosocial risk scale in patients with liver cirrhosis candidates for liver transplantation (SIPAT-11).
Garcia Morales, Natalia; (...); Cubiella, Joaquin
Article. 10.1016/j.gastrohep.2024.502220. 2024
Addressing the Burden and Management Strategies for Disparities and Inequities Among Liver Transplant Professionals: The ILTS Experience.
Andacoglu, Oya; (...); Selzner, Nazia
Article. 10.3389/ti.2023.11240. 2023
An international, multicenter, survey-based analysis of practice and management of acute liver failure.
Gurakar, Ahmet; (...); Coilly, Audrey
Article. 10.1097/LVT.0000000000000402. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Assessment of persistent COVID-19 in liver transplant recipients compared to immunocompetent individuals
Fernandez, A.; (...); Salcedo, M. M.
Meeting Abstract. 2023
CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)
Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda
Correction. 10.1016/j.rec.2023.03.018. 2023
Clinical presentation, causative drugs and outcome of patients with autoimmune features in two prospective DILI registries.
Garcia-Cortes, Miren; (...); Andrade, Raul J.
Article. 10.1111/liv.15623. 2023
CMV reactivation (rCMV) is associated with lower hepatocellular carcinoma (HCC) recurrence after liver transplatatoin (LT)
Aguilera, V.; (...); Berenguer, M.
Meeting Abstract. 2023
CMV reactivation after liver transplantation (LT) in HIV infected is similar to non-HIV patients: a single center comparative study
Garcia-Garcia, Sonia; (...); Aguilera Sancho, Victoria
Meeting Abstract. 2023
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 recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Cytomegalovirus reactivation is associated with lower hepatocelullar carcinoma recurrence rates after liver transplantation
Aguilera Sancho, Victoria; (...); Rodriguez-Peralvarez, Manuel
Meeting Abstract. 2023
Cytomegalovirus specific polyfunctional t-cells control CMV reactivation, after liver transplantation
Carvalho-Gomes, Angela; (...); Sancho, Victoria Aguilera
Meeting Abstract. 2024
Characterization of drug-induced liver injury associated with drug reaction with eosinophilia and systemic symptoms in two prospective DILI registries.
Medina-Caliz, Inmaculada; (...); Alvarez-Alvarez, Ismael
Article. 10.1007/s00204-023-03630-0. 2023
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
Development and validation of a scoring system to predict response to obeticholic acid in primary biliary cholangitis.
De Vincentis, Antonio; (...); Carbone, Marco
Article. 10.1016/j.cgh.2024.05.008. 2024
Development and validation of an image biomarker to identify metabolic dysfunction associated steatohepatitis: MR-MASH score
Marti-Aguado, David; (...); Marti-Bonmati, Luis
Article. 10.1111/liv.15766. 2024
Does colectomy improve survival in patients with ulcerative colitis undergoing liver transplant for autoimmune liver diseases?
Trapero-Marugan, M.; (...); Cuervas-Mons, V.
Meeting Abstract. 2023
Early liver transplantation for acute alcoholic hepatitis In a spanish liver transplant center
Aguilera Sancho, Victoria; (...); Berenguer, Marina
Meeting Abstract. 2023
EFFECTIVENESS AND SAFETY OF SECOND-LINE THERAPY IN PRIMARY BILIARY CHOLANGITIS (PBC): A PROSPECTIVE MULTICENTER REAL-WORLD COHORT
Gomez-Dominguez, Elena; (...); Fernandez-Rodriguez, Conrado
Meeting Abstract. 2023
Excess waitlist mortality and survival benefit of liver transplantation for patients with severe acute-on-chronic liver failure: Interim results of the CHANCE study
Gustot, Thierry; (...); Jalan, Rajiv
Meeting Abstract. 2024
External validation of models to predict hepatocellular carcinoma (HCC) in HCV SVR F3-F4 patients
Sahuco, Ivan; (...); Berenguer, Marina
Meeting Abstract. 2023
External validation of models to predict hepatocellular carcinoma in Hepatitis C Virus cured F3-F4 patients.
Carvalho-Gomes Â; (...); Berenguer M
Article. 10.1002/ueg2.12571. 2024
FibroScan compared to liver biopsy for accurately detecting recurrent hepatic steatosis and fibrosis after liver transplantation for metabolic dysfunction-associated steatohepatitis
Martinez-Arenas, Laura; (...); Berenguer, Marina
Meeting Abstract. 2024
FibroScan compared to liver biopsy for accurately detecting recurrent hepatic steatosis and fibrosis after liver transplantation for metabolic dysfunction-associated steatohepatitis
Martinez-Arenas, L.; (...); Berenguer, M.
Meeting Abstract. 2024
FibroScan compared to liver biopsy for accurately staging recurrent hepatic steatosis and fibrosis after transplantation for MASH.
Martinez-Arenas, Laura; (...); Berenguer, Marina
Article. 10.1111/liv.16085. 2024
GEMA-Na and MELD 3.0 severity scores to address sex disparities for accessing liver transplantation: a nationwide retrospective cohort study.
Rodríguez-Perálvarez ML; (...); Gastaca M
Article. 10.1016/j.eclinm.2024.102737. 2024
Gender differences in liver transplantation (LT) for acute liver failure (ALF) in a multicentre ALF-LT Spanish cohort
Conde, Isabel; (...); Aguilera Sancho, Victoria
Meeting Abstract. 2023
Gender differences in liver transplantation (LT) for acute liver failure (ALF) in a multicentre ALF-LT Spanish cohort
Conde, I.; (...); Aguilera, V.
Meeting Abstract. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Hepatorenal syndrome markedly impacts prognosis of patients with alcohol-associated hepatitis. Results from the spanish registry of alcohol-associated liver disease (REHALC)
Gratacos-Gines, Jordi; (...); Pose, Elisa
Meeting Abstract. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Incidence of de novo tumors after liver transplantation (LT) in HIV infected is similar to non-HIV patients: a single center comparative study
Chafer, Isabel Terol; (...); Sancho, Victoria Aguilera
Meeting Abstract. 2023
Incidence of fungal and other opportunistic infections in patients with autoimmune hepatitis: a spanish multicentre study
Diaz-Gonzalez, Alvaro; (...); Crespo, Javier
Meeting Abstract. 2024
Increased cardiovascular risk post-LT in HIV-infected patients? An ELTR based multicenter study
Vinaixa, C.; (...); Aguilera, M. V.
Meeting Abstract. 2024
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Liver Transplantation for Porto-Sinusoidal Vascular Liver Disorder: Long-term Outcome.
Magaz, Marta; (...); Garcia-Pagan, Juan Carlos
Article. 10.1097/TP.0000000000004444. 2022
Long-term prospective follow-up of a primary biliary cholangitis (PBC) multicenter cohort treated with Obeticholic Acid (OCA). Interaction effect of triple therapy with fibrates
Gomez-Dominguez, Elena; (...); Fernandez-Rodriguez, Conrado
Meeting Abstract. 2023
Management of cytomegalovirus in adult solid organ transplant patients: GESITRA-IC-SEIMC, CIBERINFEC, and SET recommendations update.
Ruiz-Arabi, Elisa; (...); Aguado, Jose Maria
Article. 10.1016/j.trre.2024.100875. 2024
MRI-PDFF captures the whole spectrum of lipid composition beyond traditional histological evaluation of macrosteatosis
Marti-Aguado, David; (...); Marti-Bonmati, Luis
Meeting Abstract. 2023
Multidrug-resistant bacterial infections after liver transplantation: prevalence, impact, and risk factors
Martin-Mateos, R.; (...); Albillos, A.
Meeting Abstract. 2024
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
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
Outcomes of re-referrals of patients with alcohol-associated liver disease, who were previously declined for liver transplantation.
Cox B; (...); Selzner N
Article. 10.1097/LVT.0000000000000274. 2023
Pancreatic steatosis and iron overload increases cardiovascular risk in non-alcoholic fatty liver disease.
Marti-Aguado D; (...); Marti-Bonmati L
Article. 10.3389/fendo.2023.1213441. 2023
Porto sinusoidal vascular liver disorder: natural history and long-term outcome
Magaz, Marta; (...); Garcia Pagan, Juan Carlos
Meeting Abstract. 2023
Porto-sinusoidal vascular liver disorder with portal hypertension: Natural History and Long-Term Outcome.
Magaz, Marta; (...); Garcia-Pagan, Juan Carlos
Article. 10.1016/j.jhep.2024.07.035. 2024
PREDICTION OF BIOCHEMICAL RESPONSE IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS TREATED WITH OBETICHOLIC ACID: DERIVATION AND EXTERNAL VALIDATION OF THE OCA RESPONSE SCORE (ORS)
De Vincentis, Antonio; (...); Carbone, Marco
Meeting Abstract. 2023
Predictive models of treatment benefit in patients with autoimmune hepatitis and decompensated cirrhosis at diagnosis
Arvaniti, Pinelopi; (...); Carlota Londono, Maria
Meeting Abstract. 2023
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Primary sclerosing cholangitis as an indication for liver transplantation. Results and conditioning factors: relationship with associated intestinal pathology
Fernandez, Ainhoa; (...); Salcedo, Magdalena
Meeting Abstract. 2023
Primary sclerosing cholangitis as an indication for liver transplantation. Results and conditioning factors: relationship with associated intestinal pathology
Fernandez-Yunquera, A.; (...); Salcedo, M. M.
Meeting Abstract. 2023
Primary Sclerosing Cholangitis: Gender Effects in Valencia's Low-Prevalence Region.
Minguez, Alejandro; (...); Berenguer, Marina
Article. 10.1007/s10620-024-08368-y. 2024
Proceedings of the 27th Annual Congress of the International Liver Transplantation Society.
Campos-Varela, Isabel; (...); De Martin, Eleonora
Article. 10.1097/TP.0000000000004637. 2023
Proceedings of the 28th annual congress of the international liver transplantation society.
Shaji Mathew, Johns; (...); Chadha, Ryan
Article. 10.1097/LVT.0000000000000330. 2024
Prognosticating hepatocellular carcinoma before and after liver transplantation with HepatoPredict
Silva, Silvia Gomes; (...); Cardoso, Joana
Meeting Abstract. 2024
Prophylaxis for tuberculosis and pneumocystis jirovecii does not seem necessary in patients with autoimmune hepatitis treated with corticosteroid therapy: spanish multicentre study
Diaz-Gonzalez, Alvaro; (...); Crespo, Javier
Meeting Abstract. 2024
Real-life effectiveness of voxilaprevir/sofosbuvir/velpatasvir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir
Ruiz-Cobo, Juan Carlos; (...); Lens, Sabela
Meeting Abstract. 2023
Recompensation following an episode of alcohol-associated hepatitis mostly occurs in the first year of follow-up and is related to Child-Pugh score, levels of GGT and platelets, and alcohol abstinence
Gratacos, Jordi; (...); Pose, Elisa
Meeting Abstract. 2023
Recurrence of Hepatocellular Carcinoma after Liver Transplantation: Clinical Patterns and Hierarchy of Salvage Treatments
Giuliani, Tommaso; (...); Lopez-Andujar, Rafael
Article. 10.1159/000539460. 2024
Recurrent alcohol-associated hepatitis is common and is associated with increased mortality.
Gratacos-Gines, Jordi; (...); Pose, Elisa
Article. 10.1097/HEP.0000000000000825. 2024
Rivaroxaban improves survival and decompensation in cirrhotic patients with moderate liver dysfunction. Double-blind, placebocontrolled trial
Puente Sanchez, Angela; (...); Garcia Pagan, Juan Carlos
Meeting Abstract. 2023
The global prospective observational study to evaluate the role of 'liver transplantation in patients with cirrhosis and severe acute-on-chronic liver failure (CHANCE)': study design, demographics and overall outcome
Gustot, Thierry; (...); Jalan, Rajiv
Meeting Abstract. 2024
The interaction between metabolic syndrome and alcohol consumption after an episode of alcohol-associated hepatitis is associated with increased mortality: results from de spanish registry of alcohol-associated liver disease (REHALC)
Gratacos-Gines, Jordi; (...); Pose, Elisa
Meeting Abstract. 2024
The role of HBIG in real life for patients undergoing liver transplantation due to HDV-related cirrhosis
Rodriguez-Tajes, Sergio; (...); Forns, Xavier
Article. 10.1111/liv.15777. 2024
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Use of HBsAg-positive donors in liver transplantation: an ILTS-EASLAASLD multisociety survey
Vinaixa, C.; (...); Terrault, N.
Meeting Abstract. 2024
Use of HBsAg-positive donors in liver transplantation: An ILTS-EASL-AASLD multisociety survey.
Vinaixa, Carmen; (...); Berenguer, Marina
Article. 10.1097/LVT.0000000000000432. 2024
Validation of the gender-equity model for liver allocation (GEMA) in a nationwide cohort of liver transplant candidates in Spain
Rodriguez-Peralvarez, Manuel; (...); Gastaca, Mikel
Meeting Abstract. 2024
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023
Very low access to early liver transplantation (LT) for acute alcoholic hepatitis (AAH) in a setting of social psychiatric contraindications
Garcia Garcia, S.; (...); Aguilera, V.
Meeting Abstract. 2023
Worldwide variations in COVID-19 vaccination policies and practices in liver transplant settings: results of a multi-society global survey.
Di Maira, Tommaso; (...); Berenguer, Marina
Article. 10.3389/frtra.2023.1332616. 2023