CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
HTD1801 (BUDCA)drug
Likely dose
HTD1801 (BUDCA) 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04604652
NCT04604652Phase 2Completed
CompareCT.gov

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

HighTide Biopharma Pty Ltd·interventional·Posted Oct 27, 2020·Updated Apr 24, 2024

In Brief

A Phase 2 clinical trial evaluating HTD1801 (BUDCA) for Primary Biliary Cholangitis and 5 related conditions. Completed, enrolled 24 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis, Biliary Tract Diseases, Bile Duct Stricture
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 27, 2020
Enrollment StartMay 27, 2021
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.7 years ago

Interventions

HTD1801 (BUDCA)drug

HTD1801 (BUDCA) 250 mg tablets. Dose 1000 mg twice daily with food for 12 weeks.