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Fibrate

Pemafibrate for Primary Biliary Cirrhosis

Phase 2
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
Participant is ≥18 years of age at consent
Be older than 18 years old
Must not have
Participant has Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on historically established diagnosis
Participant has Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 12 and 64

Summary

This trial will look at how well and how safe two different doses of K-808 (pemafibrate) work in people with Primary Biliary Cholangitis (PBC).

Who is the study for?
This trial is for people with Primary Biliary Cholangitis (PBC) who haven't had enough improvement with standard treatments like Ursodeoxycholic Acid or Obeticholic Acid. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions.
What is being tested?
The study is testing the effectiveness and safety of two different doses of a drug called K-808 (pemafibrate) compared to a placebo. Participants will randomly receive either one of the K-808 doses or a placebo to see if there's an improvement in their PBC symptoms.
What are the potential side effects?
While specific side effects for K-808 (pemafibrate) aren't listed, drugs like it can sometimes cause digestive issues, muscle pain, liver enzyme changes, and fatigue. The exact side effects will be monitored throughout the trial.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, or hemochromatosis.
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I have a liver condition known as sclerosing cholangitis.
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I have liver disease due to alcohol use.
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I have liver injury caused by medication.
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I have a history of autoimmune hepatitis or an overlap condition, confirmed by high IgG levels or positive antibodies and liver inflammation.
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I have been diagnosed with NASH.
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I have a condition causing bile duct blockage not related to primary biliary cholangitis.
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I have been diagnosed with liver cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 12 and 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 12 and 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change from baseline in serum alkaline phosphatase (ALP)
Secondary study objectives
Achievement of normalization of ALP level
Achievement of target levels of ALP and total bilirubin (TB)
Change from baseline in GLOBE risk score
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: K-808 Group BExperimental Treatment1 Intervention
K-808 (Dose B) for 64 Weeks
Group II: K-808 Group AExperimental Treatment1 Intervention
K-808 (Dose A) for 64 Weeks
Group III: Placebo + K-877 (Group B)Placebo Group2 Interventions
Placebo for 12 Weeks followed by K-808 (Dose B) for 52 Weeks
Group IV: Placebo + K-877 (Group A)Placebo Group2 Interventions
Placebo for 12 Weeks followed by K-808 (Dose A) for 52 Weeks

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
45 Previous Clinical Trials
16,301 Total Patients Enrolled
1 Trials studying Primary Biliary Cholangitis
16 Patients Enrolled for Primary Biliary Cholangitis
Andre Belous, MD, PhDStudy DirectorKowa Pharma Development Co.
Shona Pendse, MD, MMSCStudy ChairKowa Pharma Development Co.
~13 spots leftby Apr 2025
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