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Proyectos y Estudios
Estudio de fase II, aleatorizado, doble ciego, con doble simulación, controlado con placebo, para evaluar la seguridad y la eficacia de Semaglutida y la combinación a dosis fija de Cilofexor y Firsocostat, en monoterapia y en combinación, en pacientes con Cirrosis Compensada (F4) debida a Esteatohepatitis No Alcohólica (EHNA).

Estudio de fase II, aleatorizado, doble ciego, con doble simulación, controlado con placebo, para evaluar la seguridad y la eficacia de Semaglutida y la combinación a dosis fija de Cilofexor y Firsocostat, en monoterapia y en combinación, en pacientes con Cirrosis Compensada (F4) debida a Esteatohepatitis No Alcohólica (EHNA).

Datos básicos

Protocolo:: GS-US-454-6075
EUDRACT:: 2021-001445-12
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2022
Año de finalización:: 2023

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar si la combinación de semaglutida (SEMA) con la combinación de cilofexor (CILO) y firsocostat (FIR) produce una mejora de la fibrosis y la resolución de la EHNA en pacientes con cirrosis compensada debida a EHNA. Objetivos Secundarios: -Confirmar la contribución de SEMA a la resolución de la EHNA en pacientes tratados con la combinación de SEMA y CILO/FIR, comparándolos con los pacientes tratados con CILO/FIR en monoterapia. -Confirmar la contribución de CILO/FIR a la mejora de la fibrosis en pacientes tratados con la combinación de SEMA y CILO/FIR, comparándolos con los pacientes tratados con SEMA en monoterapia.

Documentos

No hay documentos

Participantes

Carmen Vinaixa Aunés

Investigador Principal
Enrique España Gregori

Colaborador/A
Isabel Conde Amiel

Investigador Colaborador
José Luis Poveda Andrés

Colaborador/A
Victoria Aguilera Sancho-Tello

Investigador Colaborador
Marina Berenguer Haym

Investigador Principal
Almudena Cubells García

Data Manager / Study Coordinator

Grupos

Hepatología experimental y Trasplante hepático

Investigador Principal

Laia Tolosa Pardo
Hepatología, Cirugia Hepatobiliopancreática y Trasplantes

Leader

Marina Berenguer Haym
Farmacogenética

Investigador Principal

María José Herrero Cervera
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Unidad mixta de investigación en enfermedades raras (CIPF)

Leader

José María Millán Salvador
Investigación en Neuroinmunología y Esclerosis Múltiple

Leader

Bonaventura Casanova Estruch

Financiadores - Promotores

GILEAD SCIENCES INC

Resultados del Ensayo Clínico

Publicaciones en Revistas 130

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

Anesthesia and Critical Care for the Prediction and Prevention for Small-for-size Syndrome: Guidelines from the ILTS-iLDLT-LTSI Consensus Conference.

Chadha, Ryan; (...); Rela, Mohamed

Article. 10.1097/TP.0000000000004803. 2023

Antireconverin antibodies in ocular chronic graft versus host disease: A new cause of nonparaneoplasic autoimmune retinopathy

Aguilar Gonzalez, Marina; (...); Espana Gregori, Enrique

Article. 10.1177/11206721221123779. 2022

Budesonide as first-line treatment in patients with autoimmune hepatitis seems inferior to standard predniso(lo)ne administration.

Diaz-Gonzalez, Alvaro; (...); Londoño MC

Article. 10.1097/HEP.0000000000000018. 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

CA125: a new biomarker in patients with Fontan circulation.

Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda

Article. 10.1016/j.rec.2022.05.029. 2022

Can endothelial biomarkers before liver transplantation together with classical cardiovasculat risk factors be useful to predict cardiovascular risk after liver transplantation

Herreras Lopez, Julia; (...); Aguilera Sancho, Victoria

Meeting Abstract. 2022

Can endothelial biomarkers before LT together with classical cardiovascular risk factors be useful to predict cardiovascular risk after LT?

Herreras, J.; (...); Aguilera, V.

Article. 2022

Cirrhosis is associated with lower serological responses to COVID-19 vaccines in patients with chronic liver disease.

Simao, Andre Lopes; (...); Castro, Rui E

Article. 10.1016/j.jhepr.2023.100697. 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

CMV reactivation is associated with lower hepatocellular carcinoma (HCC) recurrence after liver transplantation (LT)

Aguilera Sancho, Victoria; (...); Berenguer, Marina

Meeting Abstract. 2022

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

Cytomegalovirus reactivation is associated with lower hepatocelullar carcinoma recurrence rates after liver transplantation

Aguilera Sancho, Victoria; (...); Rodriguez-Peralvarez, Manuel

Meeting Abstract. 2023

Characteristics and trends of liver transplantation in a cohort of patients with primary sclerosing cholangitis: a retrospective multicenter study

Minguez, A.; (...); Berenguer, M.

Meeting Abstract. 2022

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 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

Economic Impact of European Liver and Intestine Transplantation Association (ELITA) Recommendations for Hepatitis B Prophylaxis After Liver Transplantation.

Cortesi, Paolo Angelo; (...); Belli, Luca Saverio

Article. 10.3389/ti.2023.10954. 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

EFFICACY OF OBETICHOLIC ACID (OCA) VS PLACEBO AND EXTERNAL CONTROL (EC) ON CLINICAL OUTCOMES IN PRIMARY BILIARY CHOLANGITIS (PBC)

Kowdley, Kris V.; (...); Villamil, Alejandra

Meeting Abstract. 2023

Enhanced recovery for liver transplantation: recommendations from the 2022 International Liver Transplantation Society consensus conference.

Pollok, Joerg M.; (...); Spiro, Michael

Article. 10.1016/S2468-1253(22)00268-0. 2023

ESOT Consensus Platform for Organ Transplantation: Setting the Stage for a Rigorous, Regularly Updated Development Process.

Cillo U; (...); Selzner N

Review. 10.3389/ti.2022.10915. 2022

European Society for Organ Transplantation Consensus Statement on Biomarkers in Liver Transplantation.

Berenguer M; (...); Zubair H

Article. 10.3389/ti.2023.11358. 2023

Exploring pregnancy, breastfeeding and contraception among women with Wilson disease in Spain: results from the Spanish Wilson registry

Romero-Gutierrez, Marta; (...); Marino, Zoe

Meeting Abstract. 2023

External validation of models to predict hepatocellular carcinoma (HCC) in HCV SVR F3-F4 patients

Sahuco, Ivan; (...); Berenguer, Marina

Meeting Abstract. 2023

First nationwide genetic study on Wilson disease (Spanish Wilson registry): high diversity in mutations and in use of genetic evaluation, association with clinical data and influence on diagnosis and health costs

Alonso Castellano, Pablo; (...); Garcia-Villarreal, Luis

Meeting Abstract. 2023

Frailty changes after liver transplantation in the Spanish setting. Results from a Spanish multicentre prospective cohort study

Puchades, L.; (...); Berenguer, M.

Meeting Abstract. 2023

Good post-transplant outcomes using liver donors after circulatory death when applying strict selection criteria: A propensity-score matched-cohort study.

Fernandez-de la Varga, Margarita; (...); Aguilera, Victoria

Article. 10.1016/j.aohep.2022.100724. 2022

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

Impact of COVID-19 on the liver and on the care of patients with chronic liver disease, hepatobiliary cancer, and liver transplantation: an updated EASL position paper.

Marjot, Thomas; (...); Cornberg, Markus

Article. 10.1016/j.jhep.2022.07.008. 2022

Impact of muscle mass on survival of patients with hepatocellular carcinoma after liver transplantation beyond the Milan criteria

Beumer, Berend R.; (...); IJzermans, Jan N. M.

Article. 10.1002/jcsm.13053. 2022

Impact of muscle mass on survival of patients with hepatocellular carcinoma after liver transplantation beyond the Milan criteria

Beumer, Berend; (...); Ijzermans, Jan

Meeting Abstract. 10.1002/jcsm.13053. 2022

Impact of suffering Wilson disease in Spain: an observational cross-sectional multicenter study

Marino, Zoe; (...); Anguera, Anna

Meeting Abstract. 2023

Inadequate social support decreases survival in decompensated liver cirrhosis patients.

García Morales N; (...); Cubiella, Joaquin

Article. 10.1016/j.gastrohep.2022.04.006. 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 de novo tumors after liver transplantation (LT) in HIV infected is similar to non-HIV patients: a single center comparative study

Chafer, I. Terol; (...); Sancho-Tello, M. V. Aguilera

Meeting Abstract. 2023

Lessons from population genomics for Wilson disease: Prevalence, penetrance of mutations, clinical implications and design of regional screening programmes

Alonso Castellano, Pablo; (...); Garcia-Villarreal, Luis

Meeting Abstract. 2023

Location and allocation: inequity of access to liver transplantation for patients with severe acute-on-chronic liver failure in Europe.

Artzner, Thierry; (...); Jalan, Rajiv

Article. 10.1002/lt.26499. 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

Main clinical characteristics and evolutionary events among patients suffering Wilson disease in Spain: first results from the Spanish Wilson registry

Marino, Zoe; (...); Castillo, Pilar

Meeting Abstract. 2023

Management of Established Small-for-size Syndrome in Post Living Donor Liver Transplantation: Medical, Radiological, and Surgical Interventions: Guidelines From the ILTS-iLDLT-LTSI Consensus Conference.

Kirchner, Varvara A.; (...); Rela, Mohamed

Article. 10.1097/TP.0000000000004771. 2023

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

Non-alcoholic steatohepatitis as liver transplant indication: similarities and differences between a high and a low prevalence countries

Martinez-Arenas, L.; (...); Berenguer, M.

Meeting Abstract. 2022

Non-alcoholic steatohepatitis is also becoming a major liver transplant indication in Spain, a historically low risk area

Martinez-Arenas, Laura; (...); Berenguer, Marina

Meeting Abstract. 2022

Nutritional status in hepatic encephalopathy and transjugular intrahepatic portosystemic shunt-TIPS, and strategies to improve the outcomes

Berenguer, M.

Review. 10.51821/86.2.11430. 2023

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

Optimal management of perioperative analgesia regarding immediate and short-term outcomes after liver transplantation - A systematic review, meta-analysis and expert panel recommendations

Sun, Li-Ying; (...); ERAS4OLT Org Working Grp

Review. 10.1111/ctr.14640. 2022

Post Living Donor Liver Transplantation Small-for-size Syndrome: Definitions, Timelines, Biochemical, and Clinical Factors for Diagnosis: Guidelines From the ILTS-iLDLT-LTSI Consensus Conference.

Kow, Alfred Wei Chieh; (...); Ikegami, Toru

Article. 10.1097/TP.0000000000004770. 2023

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

Preventing Small-for-size Syndrome in Living Donor Liver Transplantation: Guidelines From the ILTS-iLDLT-LTSI Consensus Conference.

Hakeem AR; (...); Rela M

Article. 10.1097/TP.0000000000004769. 2023

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

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

Recommendations for the integral diagnosis of chronic viral hepatitis in a single analytical extraction.

Crespo, Javier; (...); Calleja, Jose Luis

Practice Guideline. 10.1016/j.gastrohep.2022.09.009. 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

Re-irradiation in NSCLC High-dose RT: Control, Survival and Toxicity

Germain, J.; (...); Conde, A.

Meeting Abstract. 2023

Rising indication of non-alcoholic steatohepatitis as transplant indication in historically low risk areas

Martinez-Arenas, L.; (...); Berenguer, M.

Meeting Abstract. 2022

Risk of decompensated cirrhosis in patients with primary biliary cholangitis under first, second and third-line therapies

Lucena, Ana; (...); Ampuero, Javier

Meeting Abstract. 2023

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

Serological response and breakthrough infection after COVID-19 vaccination in patients with cirrhosis and post-liver transplant.

Mehta, Gautam; (...); Jalan, Rajiv

Article. 10.1097/HC9.0000000000000273. 2023

Should we seek complete liver tests normalization in primary biliary cholangitis? Data from ColHai registry

Diaz-Gonzalez, Alvaro; (...); del Registro, Grupo

Meeting Abstract. 2022

Significant heterogeneity in the diagnosis and long-term management of Wilson disease: Results from a large multicenter Spanish study

Berenguer, Marina; (...); GEMHEP

Article. 10.1016/j.gastrohep.2022.10.018. 2023

Similar rates of liver transplantation (LT) for acute liver failure (ALF) but changes in patient profiles in a Spanish multicentre cohort

Conde, I.; (...); Aguilera, V.

Meeting Abstract. 2023

SIMPLE SCORE TO ASSESS CARDIOVASCULAR RISK POST-LIVER TRANSPLANTATION

Di Maira, Tommaso; (...); Berenguer, Marina

Meeting Abstract. 2022

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

Straatsma Syndrome and cataract: case report and review of the literature.

Blanca, Casado-Pelaez; (...); Enrique, Espana-Gregori

Review. 10.22336/rjo.2023.67. 2023

Survey to evaluate the implementation of the recommendations on the comprehensive diagnosis of viral hepatitis in a single extraction: where are we?

Cabezas, Joaquin; (...); Crespo, Javier

Meeting Abstract. 2023

SURVEY TO EVALUATE THE IMPLEMENTATION OF THE RECOMMENDATIONS ON THE COMPREHENSIVE DIAGNOSIS OF VIRAL HEPATITIS IN A SINGLE EXTRACTION: WHERE ARE WE?

Cabezas, Joaquin; (...); Crespo Garcia, Javier

Meeting Abstract. 2023

The role of early extubation on short-term outcomes after liver transplantation - A systematic review, meta-analysis and expert recommendations

Tinguely, Pascale; (...); ERAS4OLT Org Working Grp

Review. 10.1111/ctr.14642. 2022

The role of preoperative optimization of the nutritional status on the improvement of short-term outcomes after liver transplantation? A review of the literature and expert panel recommendations

Victor, David W.; (...); ERAS4OLT Org Working Grp

Article. 10.1111/ctr.14647. 2022

Validation of the liver frailty index as an adverse outcome predictor in the spanish liver transplant setting. Results from a spanish multicentre prospective cohort study.

Puchades, L.; (...); Berenguer, M.

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

Waiting time dictates impact of frailty: A Spanish multicenter prospective study.

Puchades, Lorena; (...); Berenguer, Marina

Article. 10.1016/j.jhepr.2023.100840. 2023

What is the optimal management of thromboprophylaxis after liver transplantation regarding prevention of bleeding, hepatic artery, or portal vein thrombosis? A systematic review of the literature and expert panel recommendations

Kirchner, Varvara A.; (...); ERAS4OLT Org Working Grp

Review. 2022

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