Pemafibrate for Primary Biliary Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
How is the drug pemafibrate different from other treatments for primary biliary cirrhosis?
Who Is on the Research Team?
Sara Neville, MD
Principal Investigator
Kowa Research Institute, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of K-808 followed by an optional multiple-dose treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pemafibrate
Pemafibrate is already approved in Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kowa Research Institute, Inc.
Lead Sponsor