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Kowa K-808-2.01

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • 网红黑料y Volunteers
    No
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Objective

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Details

Full study title Kowa K-808-2.01 A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study with a 52-week Extension to Evaluate Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects with Primary Biliary Cholangitis with Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment
Protocol number OCR45205
ClinicalTrials.gov ID NCT05327127
Phase Phase 2

Eligibility

Inclusion Criteria:

  • Able to understand and comply with study procedures and give written informed consent

  • Age 鈮�18 years

  • NAS 鈮�4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization

  • Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization

  • Meet all inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

  • Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study

  • Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol

  • Evidence of other forms of chronic liver disease as defined in clinical study protocol

  • Does not meet any other exclusion criteria outlined in clinical study protocol

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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