At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 46 enrolled
Drug / intervention
HPN-100 +1 moredrug
Likely dose
HPN-100 17.4mLfrom 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 Phase 3, Randomized, Double-Blind, Cross-Over, Active-Controlled Study of the Efficacy and Safety of HPN-100, Glyceryl Tri-(4-phenylbutyrate), for the Treatment of Adults With Urea Cycle Disorders (Help UCD)
In Brief
A Phase 3 clinical trial evaluating HPN-100 and Buphenyl (NaPBA) for Urea Cycle Disorders. Completed, enrolled 46 participants across 22 sites in 2 countries.
Detailed Summary
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrea Cycle Disorders
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionSep 2010
TodayJul 2026
First PostedOct 9, 2009
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago
Interventions
HPN-100drug
HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers equivalent amount of PBA in 40 tablets of NaPBA.
Buphenyl (NaPBA)drug
Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.