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.
NCT ID: NCT06247735
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2024-02-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo + K-877 (Group A)
Placebo for 12 Weeks followed by K-808 (Dose A) for 52 Weeks
K-808 (Dose A)
Administered orally once daily
Placebo
Administered orally once daily
Placebo + K-877 (Group B)
Placebo for 12 Weeks followed by K-808 (Dose B) for 52 Weeks
K-808 (Dose B)
Administered orally once daily
Placebo
Administered orally once daily
K-808 Group A
K-808 (Dose A) for 64 Weeks
K-808 (Dose A)
Administered orally once daily
K-808 Group B
K-808 (Dose B) for 64 Weeks
K-808 (Dose B)
Administered orally once daily
Interventions
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K-808 (Dose A)
Administered orally once daily
K-808 (Dose B)
Administered orally once daily
Placebo
Administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
* Drug-induced liver injury (DILI) as defined by typical exposure and history
* Known condition that involves bile duct obstruction or cholestasis other than PBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, Caroli syndrome, congenital liver fibrosis), idiopathic ductopenia
* Hepatocellular carcinoma
18 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andre Belous, MD, PhD
Role: STUDY_DIRECTOR
Kowa Pharma Development Co.
Locations
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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
CommonSpirit Health Research Institute
Omaha, Nebraska, United States
New York University Hepatology Associates
New York, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Vanderbilt Digestive Disease Center
Nashville, Tennessee, United States
Pioneer Research Solutions
Houston, Texas, United States
UVA Health - University of Virginia Health System
Charlottesville, Virginia, United States
Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
(G.I,R,I) GI Research Institute
Vancouver, British Columbia, Canada
Office of Dr. Gauthier
North Bay, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada
306
Fukui, , Japan
313
Fukuoka, , Japan
305
Hamamatsu, , Japan
308
Hirakata, , Japan
309
Hiroshima, , Japan
304
Isehara, , Japan
303
Itabashi-ku, , Japan
312
Kanazawa, , Japan
307
Matsumoto, , Japan
311
Ōmura, , Japan
302
Sapporo, , Japan
Teine Keijinkai Hospital
Sapporo, , Japan
314
Yokohama, , Japan
Countries
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Other Identifiers
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K-808-2.01
Identifier Type: -
Identifier Source: org_study_id
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