At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
HTD1801 +1 moredrug
Likely dose
HTD1801 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)
In Brief
A Phase 2 clinical trial evaluating HTD1801 and Placebo for Primary Sclerosing Cholangitis (PSC). Completed, enrolled 59 participants across 26 sites in 2 countries.
Detailed Summary
The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis (PSC)
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionApr 2020
Study CompletionAug 2020
TodayJul 2026
First PostedNov 7, 2017
Enrollment StartFeb 9, 2018
Primary CompletionApr 30, 2020
Study CompletionAug 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.7 years ago
Interventions
HTD1801drug
HTD1801 tablets, 250 mg
Placebodrug
tablets manufactured to mimic HTD1801 tablets