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Ursodeoxycholic Acid

HTD1801 (BUDCA) for Cholangitis (PRONTO-PBC Trial)

Phase 2
Waitlist Available
Research Sponsored by HighTide Biopharma Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

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.

Eligible Conditions
  • Cholangitis
  • Cholestasis
  • Biliary Tract Disease
  • Primary Biliary Cirrhosis
  • Bile Duct Stricture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Alkaline Phosphatase (ALP) at Week 12 Compared to Baseline
Secondary outcome measures
Change in GLOBE Score Between Baseline and Week 12
Change in Immunoglobulin M (IgM) From Baseline to Week 12
Change in Pruritus as Measured by Pruritus Visual Analog Score (VAS) From Baseline to Week 12
+3 more

Side effects data

From 2022 Phase 2 trial • 24 Patients • NCT04604652
38%
Diarrhea
21%
Pruritus
17%
Abdominal Distension
17%
Liver Function Test Increased
13%
Vomiting
13%
Headache
8%
Decreased Appetite
8%
Abdominal Pain Upper
8%
Pyrexia
8%
Upper Respiratory Tract Infection
8%
Constipation
8%
Alanine Aminotransferase Increased
8%
Aspartate Aminotransferase Increased
8%
Arthralgia
8%
Oropharyngeal Pain
8%
Nausea
8%
Bronchitis
4%
COVID-19 Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
HTD1801 1000 mg BID

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
HTD1801 (BUDCA) 250 mg tablets. Dosed at 1000 mg BID with food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HTD1801 (BUDCA)
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

HighTide Biopharma Pty LtdLead Sponsor
11 Previous Clinical Trials
1,975 Total Patients Enrolled
3 Trials studying Cholangitis
91 Patients Enrolled for Cholangitis
Adrian DiBisceglie, MDStudy DirectorHighTide Therapeutics Biopharma Pty.
~6 spots leftby Sep 2025
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