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

  • Chronic Kidney Disease
Trial Status:

Active, not recruiting

This trial runs in
Cities
  • Austin
  • Barcelona
  • Baton Rouge
  • Bethesda
  • Boca Raton
  • Bordeaux
  • Bruxelles
  • cedar-park
  • Chandler
  • Chula Vista
  • clovis
  • Columbus
  • Cullman
  • Durham
  • Edegem
  • edinburg
  • Englewood
  • Fort Worth
  • Gent
  • Houston
  • Idaho Falls
  • Kansas City
  • Los Angeles
  • Lyon
  • Marietta
  • McAllen
  • Miami
  • Nice
  • north-little-rock
  • Paris
  • Pittsburgh
  • Richmond
  • San Antonio
  • San Diego
  • San Juan
  • San Marcos
  • Sarasota
  • Sevilla
  • Tucson
  • València
  • Vandœuvre-lès-Nancy
  • Ypsilanti
Trial Identifier:

NCT04171765 GC41033

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT04171765 , GC41033 Trial Identifier
      Placebo, BFKB8488A 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

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