Kowa Pbc K-808-2.01
Posted Date: Apr 25, 2024
- Investigator: Khurram Bari
- Specialties:
- Type of Study: Drug
Primary Objective: • To assess the effects on alkaline phosphatase (ALP) of two doses of K-808 compared to placebo after 12 weeks of treatment in subjects with primary biliary cholangitis (PBC) Key Secondary Objective: • To assess the effects on ALP normalization of two doses of K-808 compared to placebo after 12 weeks of treatment in subjects with PBC Secondary Objectives: • To assess the effects of two doses of K-808 on ALP and total bilirubin, together as a composite endpoint, after treatment in subjects with PBC • To assess the safety of two doses of K-808 in subjects with PBC • To assess the effects of two doses of K-808 on levels of ALP, total and conjugated bilirubin, and other liver function parameters (albumin, international normalized ratio [INR], gamma-glutamyl transpeptidase [?-GT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], fractions of ALP, platelet count, total bile acids, UDCA, chenodeoxycholic acid [CDCA], lithocholic acid [LCA], cholic acid [CA], deoxycholic acid [DCA], 7a hydroxy 4 cholesten-3-one [C4], immunoglobulin G [IgG], and immunoglobulin M [IgM]) in subjects with PBC • To assess the effects of two doses of K-808 on change in GLOBE risk scores in subjects with PBC • To assess the effects
Criteria:
1. Subject 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 2. Alp = 1.5 × Uln 3. Subject Has Been Taking: • Udca Monotherapy For At Least 12 Months At A Stable Dose For At Least 6 Months • Udca And Oca Combination Treatment For At Least 3 Additional Months (Stable Dose For =3 Months, And Starting After At Least 6 Months Of Udca Monotherapy) Prior To Screening • Unable To Tolerate Udca O Oca Monotherapy Treatment • Udca And Oca Combination Treatment (No Udca Or Oca For =3 Months) Prior To Screening 4. Males Or Females, =18 Years Of Age, Both Inclusive At Screening.
Keywords:
Pbc, Kowa
For More Information:
Adrienne Crusey
513-584-2363
cruseyla@ucmail.uc.edu