NCT04604652

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HighTide Biopharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis
• Primary Biliary Cirrhosis
• Cholangitis
• Cholestasis
• Biliary Tract Diseases
• Bile Duct Stricture

Interventions

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

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-10-27
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study