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Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the 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

NCT06247735•Kowa Research Institute, Inc.

View on ClinicalTrials.gov

Summary

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy 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:
•* History of ALP above ULN for at least 6 months
•* History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titer
•* Historical liver biopsy consistent with PBC
•Participant has the following qualifying biochemistry value at Screening:
•* ALP ≥1.5 × ULN
•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:
•* ALP\>10 × ULN
•* ALT or AST \>5 × ULN
•* Hepatitis C treatment within 5 years of Screening, or active hepatitis C as defined by positive hepatitis C antibody with the presence of hepatitis C virus ribonucleic acid; subjects with active hepatitis B (HBV) infection (hepatitis B surface antigen \[HbsAg\] positive) will be excluded. A subject with resolved hepatitis A at least 3 months prior to the Screening Visit can be screened.
•* Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)
•* Alcoholic liver disease
•* History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap, defined as both of the following: 1) IgG \>2 × ULN and/or positive anti-smooth muscle antibodies, 2) liver histology revealing moderate or severe periportal or periseptal inflammation
•* Nonalcoholic steatohepatitis (NASH)
•* Gilbert's Syndrome
•* Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on historically established diagnosis
+3 more criteria

Locations (38)

UA Thomas D. Boyer Liver Institute

Tucson, Arizona, United States

Southern California Research Center - Coronado

Coronado, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Velocity Clinical Research

Santa Ana, California, United States

Peak Gastroenterology Associates Colorado Springs

Colorado Springs, Colorado, United States

University of Florida Hepatology Research at CTRB

Gainesville, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami Leonard M. Miller School of Medicine

Miami, Florida, United States

Springfield Clinic

Springfield, Illinois, United States

Mercy Medical Center - Mcauley Plaza

Baltimore, Maryland, United States

Key Dates

Start Date

February 7, 2024

Primary Completion Date

June 26, 2025

Completion Date

June 1, 2026

Last Updated

September 10, 2025

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cholangitis

Interventions

K-808 (Dose A)

DRUG

K-808 (Dose B)

DRUG

Placebo

DRUG

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

NCT07304843

Primary Biliary Cholangitis (PBC)

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RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Biochemical Response and Clinical Outcomes in Patients With PBC

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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy