CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 189 enrolled
Drug / intervention
HPN-100 +1 moredrug
Likely dose
HPN-100 6 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/NCT00999167
NCT00999167Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

Amgen·interventional·Posted Oct 21, 2009·Updated Jul 10, 2024

In Brief

A Phase 2 clinical trial evaluating HPN-100 and Placebo for Cirrhosis and Hepatic Encephalopathy. Completed, enrolled 189 participants across 28 sites.

Detailed Summary

This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis, Hepatic Encephalopathy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2009
Enrollment StartDec 1, 2009
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.7 years ago

Interventions

HPN-100drug

Part B: 6 mL BID for 16 weeks.

Placebodrug

Part B: same as experimental arm