NIPH Clinical Trials Search

A Long-term Study (Phase III) of KC-8025 in Patients with Primary Biliary Cholangitis and Inadequate Response to or Intolerance of Ursodeoxycholic Acid

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Primary biliary cholangitis
Date of first enrollment	30/03/2026
Target sample size	29
Countries of recruitment
Study type	Interventional
Intervention(s)	KC-8025 10 mg will be taken orally once daily, and one capsule will be taken per dose.Patients with an inadequate response to UDCA will continue UDCA treatment with the same dosage and administration as used in the KC-8025-02 study. However, changes to the dosage and administration of UDCA are permitted only if PBC worsens and is considered an adverse event.

Outcome(s)

Primary Outcome	- Adverse event - Other safety endpoint defined in the clinical study protocol
Secondary Outcome	- Achievement of the composite endpoint (every 13 weeks after administration) - Achievement of ALP <= ULN (every 13 weeks after administration) - Other efficacy endpoint defined in the clinical study protocol

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who have completed the 52-week treatment period in the KC-8025-02 study and wish to continue administration of KC-8025
Exclude criteria	- Patients with decompensated cirrhosis as defined in this clinical study protocol - Patients with a Child-Pugh score of 7 or higher (class B or above) - Female patients who are pregnant, breastfeeding, or may be pregnant, or who wish to become pregnant after providing informed consent until 90 days after the last dose of the investigational product, or male patients who wish to father a child. - Patients who experienced Grade 3 or higher adverse events in the KC-8025-02 study that were considered related to the investigational product. - Patients who meet any other exclusion criteria outlined in this clinical study protocol