Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526665 - Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Phase 3
Recruiting NCT02931513 - sCD163 in PBC Patients - Assessment of Treatment Response
Active, not recruiting NCT02924701 - sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
Completed NCT02659696 - Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Completed NCT02078882 - Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis Phase 4
Completed NCT01389973 - A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid Phase 2
Completed NCT01603199 - High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis N/A
Completed NCT01857284 - Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Phase 3
Completed NCT05374200 - Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC) N/A
Recruiting NCT02937012 - Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Phase 3
Completed NCT02376335 - B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Phase 2
Recruiting NCT01662973 - Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis Phase 1/Phase 2
Active, not recruiting NCT04751188 - A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Phase 3
Recruiting NCT04514965 - Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting NCT03668145 - Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis N/A
Completed NCT02955602 - Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) Phase 2
Completed NCT02557360 - Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis Phase 4
Recruiting NCT01440309 - Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Phase 1
Completed NCT01249092 - Pentoxifylline for Primary Biliary Cirrhosis Phase 2
Completed NCT01510860 - Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis Phase 4