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Fibrate

Pemafibrate for Primary Biliary Cirrhosis

Phase 1
Recruiting
Research Sponsored by Kowa Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participant is ≥18 years of age at consent
Participant has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria: History of ALP above ULN for at least 6 months, History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titers, Historical liver biopsy consistent with PBC
Must not have
Female subject of childbearing potential who is known to be pregnant, has a positive pregnancy test (serum test, or urine test that is confirmed by a positive serum pregnancy test), or is lactating and breastfeeding, or planning to become pregnant or breastfeed during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study how a medication called K-808 (Pemafibrate) works in people with Primary Biliary Cholangitis, with or without cirrhosis. It will look at

Who is the study for?
This trial is for adults over 18 with Primary Biliary Cholangitis (PBC), either with well-compensated cirrhosis or without. Participants must have a history of liver enzyme levels above normal and positive antibodies related to PBC. They should understand the study procedures and agree to follow them.
What is being tested?
The trial is testing K-808, also known as Pemafibrate, in patients with PBC. It aims to understand how the drug moves through and affects the body (pharmacokinetics) and its safety profile in those with compensated cirrhosis compared to those without.
What are the potential side effects?
While specific side effects are not listed here, generally, pharmacokinetic studies like this one monitor for any changes in organ function, allergic reactions, gastrointestinal symptoms, fatigue or other unexpected health issues related to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with PBC based on my medical history and test results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PBC w/o CIRRExperimental Treatment1 Intervention
K-808 single dose followed by multiple-dose treatment period.
Group II: PBC w/ CIRR CP-AExperimental Treatment1 Intervention
K-808 single dose followed by optional multiple-dose treatment period.

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Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
45 Previous Clinical Trials
16,330 Total Patients Enrolled
Sara Neville, MDStudy DirectorKowa Research Institute, Inc.
~11 spots leftby Apr 2025
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