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Estudio demostrativo preliminar de fase IIa, multicéntrico, aleatorizado, abierto y controlado para evaluar la eficacia, seguridad y tolerabilidad de VS-01 además del tratamiento estándar, en comparación con el tratamiento estándar solo, en pacientes adultos con insuficiencia hepática crónica agudizada (IHCA) de grado 1-2 y ascitis.

Estudio demostrativo preliminar de fase IIa, multicéntrico, aleatorizado, abierto y controlado para evaluar la eficacia, seguridad y tolerabilidad de VS-01 además del tratamiento estándar, en comparación con el tratamiento estándar solo, en pacientes adultos con insuficiencia hepática crónica agudizada (IHCA) de grado 1-2 y ascitis.

Datos básicos

Protocolo:: VS01-IIa-01
EUDRACT:: 2021-002617-33
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2023
Año de finalización:

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Comparar la eficacia del VS-01 administrado por vía intraperitoneal (i.p.) una vez al día durante 4 días en pacientes con IHCA de grado 1 y 2 además del tratamiento estándar con la administración del tratamiento estándar solo. Objetivos Secundarios: 1.Caracterizar seguridad y tolerabilidad de VS-01 en pacientes con IHCA tras administración ip de VS-01 1 vez al día durante 4 días 2.Evaluar eficacia de VS-01 en pacientes con IHCA tras administración ip de VS-01 1 vez al día durante 4 días además de tratamiento estándar y tratamiento estándar solo: a.Efecto de puntuación CLIF-C ACLF en Día 5 b.Evolución de puntuación CLIF-C ACLF c.Evolución grado IHCA d.Efecto en insuficiencias orgánicas(puntuación CLIF-C OF) e.Efecto en disfunciones orgánicas(puntuación CLIF-SOFA) f.Efecto en CPS,MELD y MELD-NA 3.Evaluar efecto de VS-01 en EH en pacientes con IHCA tras administración ip de VS-01 1 vez al dia durante 4 días además de tratamiento estándar y tratamiento estándar solo: a.Efecto grado West Haven b.Evolución grado West Haven c.Efecto en EH encubierta d.Efecto en EH manifiesta e.Evolución EH manifiesta 4.Caracterizar perfiles FC y FD de VS-01 en pacientes con IHCA tras administración de VS-01 ip 1 vez al dia durante 4 dias

Documentos

No hay documentos

Participantes

María García Eliz

Investigador Colaborador
Carmen Vinaixa Aunés

Investigador Principal
Isabel Conde Amiel

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
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
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

Versantis AG

Resultados del Ensayo Clínico

Publicaciones en Revistas 87

[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

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

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

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

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

Characterizing chronic hepatitis delta in Spain and the gaps in its management

Rodriguez-Tajes, Sergio; (...); Lens, Sabela

Meeting Abstract. 2023

Characterizing Hepatitis Delta in Spain and the gaps in its management.

Rodriguez-Tajes, Sergio; (...); Lens, Sabela

Article. 10.1016/j.gastrohep.2024.502222. 2024

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 (vol 22, pg 2062, 2024)

De Vincentis, A.; (...); Conde, Isabel

Correction. 2025

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

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

HepatoPredict Accurately Selects Hepatocellular Carcinoma Patients for Liver Transplantation Regardless of Tumor Heterogeneity

Andrade, Rita; (...); Cardoso, Joana

Article. 10.3390/cancers17030500. 2025

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

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

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

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

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

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

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

Recurrence of Hepatocellular Carcinoma after Liver Transplantation: Clinical Patterns and Hierarchy of Salvage Treatments

Giuliani, Tommaso; (...); Lopez-Andujar, Rafael

Article. 10.1159/000539460. 2024

The 2024 ILTS-ILCA consensus recommendations for liver transplantation for hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

Kodali, Sudha; (...); Sapisochin, Gonzalo

Article. 10.1097/LVT.0000000000000589. 2025

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 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 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

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

Datos básicos

Objetivos del proyecto

Documentos

Participantes

Grupos

Financiadores - Promotores

Resultados del Ensayo Clínico

Campos de Estudio

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