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Phase III clinical trial to evaluate the efficacy and safety of elafibranor on long-term clinical outcomes in adult participants with primary biliary cholangitis (PBC).

THE OBJECTIVE OF THIS CLINICAL TRIAL IS TO LEARN ABOUT THE BENEFITS AND LONG-TERM RISKS/SIDE EFFECTS OF REPEATED TREATMENT FOR PRIMARY BILIARY CHOLANGITIS (PBC).

Imagen de la Dra. Delia D'vola, especialista en Medicina Interna. La Dra. D'Avola trabaja en el eepartamento de Hepatología de la Clínica Universidad de Navarra. Se dedica preferencialmente a hepatocarcinoma, cirrosis y trasplante hepático y porfirias agudas.
Dr. Delia D'Avola [SP] Curriculum
Specialist Hepatology Unit
Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Madrid

Technical Summary

  • PHASE III, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELAFIBRANOR 80 MG ON LONG-TERM CLINICAL OUTCOMES IN ADULT PARTICIPANTS WITH PRIMARY BILIARY CHOLANGITIS (PBC).
  • Code EudraCT: 2023-505251-43-00
  • Protocol number: CLIN-60190-454
  • Promoter: IPSEN
  • Molecule/Drug: Elafibranor
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.