Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
Participant gender:
Summary
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801
(BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard
therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase
at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite
of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at
13-15 mg/kg for at least 6 months.