CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
HPN-100drug
Likely dose
HPN-100 17.4 mLfrom 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.

Search/NCT00947297
NCT00947297Phase 3Completed
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A Phase 3, Open-Label Study of the Safety of HPN-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)

Amgen·interventional·Posted Jul 28, 2009·Updated Jul 10, 2024

In Brief

A Phase 3 clinical trial evaluating HPN-100 for Urea Cycle Disorders. Completed, enrolled 60 participants across 22 sites in 2 countries.

Detailed Summary

This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrea Cycle Disorders
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 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 (\~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do.