Status and phase
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About
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female participant who has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria:
Participant has the following qualifying biochemistry value at Screening:
Participant is ≥18 years of age at consent.
Participant meets all other eligibility criteria outlined in the Clinical Study Protocol.
Exclusion criteria
Participant meets any one of the following criteria at Screening:
Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 4 patient groups, including a placebo group
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Central trial contact
Director, Clinical Operations
Data sourced from clinicaltrials.gov
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