Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis (NCT04604652) | Clinical Trial Compass
CompletedPhase 2
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
United States24 participantsStarted 2021-05-27
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Biochemical evidence of cholestasis with elevation of ALP activity
. Presence of antimitochondrial antibody (AMA)
. Histopathologic evidence of non-suppurative cholangitis and destruction of small or medium-sized bile ducts if biopsy performed Note: historical AMA and liver biopsy data may be used but must be recorded in source documentation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a drug called HTD1801 for primary biliary cholangitis and looked at whether it reduced alkaline phosphatase levels after 12 weeks — can you tell me what the results showed, and whether a drop in ALP is something that could matter for my specific situation?
2Since this was a Phase 2 trial, the main goal was to see if HTD1801 showed enough promise to study further — does that mean there's still limited safety data compared to already-approved treatments like obeticholic acid or ursodiol, and how should that affect my thinking?
3The trial is now completed but I don't know if it led to a Phase 3 study or whether HTD1801 is moving toward approval — do you know the current status of this drug's development, and is there any way for me to access it now?
4Given that my ALP level is something you already monitor, how does my current ALP compare to what this kind of trial would typically be trying to improve, and does that help you judge whether this research is relevant to my case?
5Are there other ongoing trials or standard treatments I should consider first before looking at something like HTD1801, especially since this study is already closed to new participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Alkaline Phosphatase (ALP) at Week 12 Compared to Baseline