Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for PBC patients: experimental drug K-808 enters Mid-Stage trial

NCT ID NCT06247735

Disease control Sponsor: Kowa Research Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests two doses of K-808 (Pemafibrate) in 46 adults with primary biliary cholangitis (PBC) who haven't responded well to standard treatments. The main goal is to see if the drug lowers alkaline phosphatase (ALP) levels, a key marker of liver damage, after 12 weeks. Participants will be followed for up to a year to check safety and long-term effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pemafibrate (K-808)
What this could lead to
If successful, this could offer a new treatment option for people with primary biliary cholangitis who don't respond well to current therapies.
What could go wrong
This is an early Phase 2 trial with only 46 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Primary biliary cholangitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

  • (G.I,R,I) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5, Canada

  • 302

    Sapporo, Japan

  • 303

    Itabashi-ku, Japan

  • 304

    Isehara, Japan

  • 305

    Hamamatsu, Japan

  • 306

    Fukui, Japan

  • 307

    Matsumoto, Japan

  • 308

    Hirakata, Japan

  • 309

    Hiroshima, Japan

  • 311

    Ōmura, Japan

  • 312

    Kanazawa, Japan

  • 313

    Fukuoka, Japan

  • 314

    Yokohama, Japan

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

    Montreal, Quebec, H2X 0A9, Canada

  • CommonSpirit Health Research Institute

    Omaha, Nebraska, 68124, United States

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141, United States

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Mercy Medical Center - Mcauley Plaza

    Baltimore, Maryland, 21202, United States

  • New York University Hepatology Associates

    New York, New York, 10016, United States

  • Office of Dr. Gauthier

    North Bay, Ontario, P1B 2H3, Canada

  • Peak Gastroenterology Associates Colorado Springs

    Colorado Springs, Colorado, 80921, United States

  • Pioneer Research Solutions

    Houston, Texas, 77099, United States

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701, United States

  • Southern California Research Center - Coronado

    Coronado, California, 92118, United States

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • Teine Keijinkai Hospital

    Sapporo, Japan

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • UA Thomas D. Boyer Liver Institute

    Tucson, Arizona, 85724, United States

  • UVA Health - University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610, United States

  • University of Miami Leonard M. Miller School of Medicine

    Miami, Florida, 33136, United States

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37232, United States

  • Velocity Clinical Research

    Santa Ana, California, 92704, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.