A study of a new medicine (fazpilodemab) in people with a type of liver disease called non-alcoholic steatohepatitis or NASH

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

  • Metabolic Disorder
  • Non Alcoholic Steato-Hepatitis
  • Kidney Disorder
  • Chronic Kidney Disease
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Countries
  • Belgium
  • France
  • Puerto Rico
  • Spain
  • United States
Trial Identifier:

NCT04171765 GC41033

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This clinical trial investigated a new medicine called, “fazpilodemab.” Patients with liver disease (non-alcoholic steatohepatitis or NASH) joined the study to find out if fazpilodemab treatments were effective for NASH. The name of this disease has now changed to “metabolic dysfunction-associated steatohepatitis” or MASH. In this study, people were randomly assigned to three fazpilodemab dose groups and a placebo group. Treatments were double-blind, given by injection once every two weeks for about a year. Researchers used a scale to grade liver disease before and after treatment, paying attention to inflammation, ballooning, fat build-up in liver cells (steatosis), and scarring (fibrosis).

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 2 Phase
      NCT04171765,GC41033 Trial Identifier
      Placebo, BFKB8488A, fazpilodemab Treatments
      Non-alcoholic Steatohepatitis Condition
      Official Title

      A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
      • Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization
      Exclusion Criteria
      • History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
      • Weight gain > 10% or loss > 5% within 3 months prior to randomization
      • History of liver transplantation
      • Current or history of significant alcohol consumption

      For the latest version of this information please go to www.forpatients.roche.com

       

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