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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 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.

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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).

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

FieldValue
Enrollment Target 189 participants
Start Date 2009-12
Est. Completion 2012-04
Phase Phase 2

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT00999167

The ClinicalTrials.gov registry entry for NCT00999167 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.