Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

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.

Timeline

Start

2021-05-27

Primary completion

2022-05-31

Completion

2022-05-31

Drugs

Indications