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A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

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Trial Profile

A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Dec 2023

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At a glance

  • Drugs Cenicriviroc (Primary) ; Tropifexor (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Adverse reactions
  • Acronyms TANDEM; TANDEM NASH
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals

    • Most Recent Events

    • 14 Nov 2023 Results from NCT03517540, NCT03912532 deriving baseline/screening biopsies evaluating the utility of the HistoIndex artificial intelligence (AI) digital pathology tool to improve the reliability of fibrosis staging in NASH, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 14 Nov 2023 Results from the Tandem study analyzing reduction screen failure rates using ballooning and fibrosis assessment with second harmonic generation/Two-Photon excitation microscopy and artificial intelligence analysis, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 11 May 2023 Results assessing safety and efficacy of TXR and CVC combination, compared with respective monotherapies published in the Hepatology
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