Study Condition(s): Liver Disease

A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA

Study Alias: JAIV

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT03742973 {{ currentLocaleObject.registryAnchorText }}

Withdrawn Not yet recruiting

Study Purpose

This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

The study will last about 16 weeks and may include up to 7 visits.
  • Participants must have a diagnosis of PBC

  • Participants must be taking UDCA in a stable dose or have previously taken, but are intolerant

  • Participants must not have other liver diseases including:

    • Hepatitis C virus (HCV)
    • Hepatitis B virus (HBV) infection
    • Primary sclerosing cholangitis
    • Alcoholic liver disease
    • Autoimmune liver disease other than PBC, such as overlap hepatitis
    • Nonalcoholic steatohepatitis
    • Gilbert’s syndrome

  • Participants must not have a history of VTE (deep vein thrombosis/pulmonary embolism [DVT/PE])

  • Participants must not have a current or recent clinically serious infection

  • Participants must not are receiving unstable treatment for pruritus

  • Participants must not have received obeticholic acid

  • Participants must not have received fenofibrate or other fibrates for the treatment of PBC

Where to Participate

19 locations are currently available of 27 planned
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