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

Primary Biliary Cirrhosis Clinical Trial

Official title:
A Phase 2 Open Label, Proof of Concept Study of HTD1801 (BUDCA) in Adult Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to Standard Therapy - PRONTO-PBC

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04604652
Study type Interventional
Source HighTide Biopharma Pty Ltd
Contact
Status Completed
Phase Phase 2
Start date May 27, 2021
Completion date May 31, 2022
View Details
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