NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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.

NCT06247735

Active Not RecruitingPhase 2

Sponsor: Kowa Research Institute, Inc.

Conditions: Primary Biliary Cholangitis

Interventions: K-808 (Dose A), K-808 (Dose B), Placebo

Countries: United States, Canada, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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
  * 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
* Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.

Locations (38)

Tucson, Arizona, United States
Coronado, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Gainesville, Florida, United States
Lakewood Rch, Florida, United States
Miami, Florida, United States
Springfield, Illinois, United States
Baltimore, Maryland, United States
Omaha, Nebraska, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Vancouver, British Columbia, Canada
North Bay, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Fukui, Japan
Fukuoka, Japan
Hamamatsu, Japan
Hirakata, Japan
Hiroshima, Japan
+ 8 more on CT.gov