World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 29 July 2022
Main ID:  NCT04604652
Date of registration: 16/10/2020
Prospective Registration: Yes
Primary sponsor: HighTide Biopharma Pty Ltd
Public title: Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis PRONTO-PBC
Scientific 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
Date of first enrolment: May 27, 2021
Target sample size: 22
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT04604652
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Adrian DiBisceglie, MD
Address: 
Telephone:
Email:
Affiliation:  HighTide Therapeutics Biopharma Pty.
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history