Primary biliary cholangitis
Conditions
Interventions
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
Sponsors
Kawabata Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have completed the 52-week treatment period in the KC-8025-02 study and wish to continue administration of KC-8025
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Adverse event - Other safety endpoint defined in the clinical study protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Contacts
Public ContactTrial Contact for
Kaken Pharmaceutical Co., Ltd.
Outcome results
None listed