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NCT00999167 · ClinicalTrials.gov registry record · Phase 2
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
A Phase 2 study of Cirrhosis and Hepatic Encephalopathy, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
- 20
- Study locations
NCT00999167: Completed Phase 2 study of Cirrhosis and Hepatic Encephalopathy, sponsored by Amgen.
NCT00999167 is a Phase 2 study of Cirrhosis and Hepatic Encephalopathy that has completed, run by Amgen. The registered enrollment target is 189 participants, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00999167, a Phase 2 study of Cirrhosis and Hepatic Encephalopathy, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HPN-100
Study Locations (20)
New York
- Concorde Medical Group PLLC - New York
- NYU Medical Center - New York
- Mount Sinai Medical Center - New York
- Columbia University Medical Center / Center for Liver Disease and Transplantation - New York
- University of Rochester Medical Center - Rochester
- New York Medical College / Westchester Medical Center - Valhalla
Florida
- University of Miami / Center for Liver Diseases - Miami
- Tampa General Hospital - Tampa
California
- Stanford University Medical Center, Division of Gastroenterology and Hepatology - Palo Alto
District of Columbia
- Georgetown University Hospital - Washington D.C.
Illinois
- The University of Chicago Medical Center - Chicago
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT00999167 record still lists
NCT00999167 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00999167 names 20 study sites across 14 states, led by New York, Florida, California.
Frequently Asked Questions
What is clinical trial NCT00999167 about?
NCT00999167 is a clinical study titled "A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy". 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).
What is the current status of trial NCT00999167?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2009-12. Estimated completion is 2012-04.
What conditions does trial NCT00999167 study?
This clinical trial studies the following conditions: Cirrhosis, Hepatic Encephalopathy.
What interventions are being tested in trial NCT00999167?
The interventions under investigation include: Placebo (DRUG), HPN-100 (DRUG).
Who is sponsoring clinical trial NCT00999167?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00999167 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00999167's enrollment target sits among peer trials
189 14th of 53 higher than 40 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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