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
ENSAYO CLÍNICO

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

Participantes

Grupos

Financiadores - Promotores

MADRIGAL PHARMACEUTICALS,INC.(NO USAR!!)

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

  • Open Access.

[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

  • Open Access.

[Translated article] New challenges in advanced therapies.

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

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


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