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NCT00597909 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy

A Phase 2 study, sponsored by Amgen.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT00597909 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 1 participants.

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The verdict

NCT00597909, a Phase 2 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study Summary

The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

Interventions

  • DRUG sodium phenylacetate and sodium benzoate injection 10% / 10%
  • DRUG placebo solution (10% dextrose)

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2007-12
Est. Completion 2008-09
Phase Phase 2

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT00597909

The ClinicalTrials.gov registry entry for NCT00597909 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which sodium phenylacetate and sodium benzoate injection 10% / 10% is the first listed.

NCT00597909 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00597909 about?

NCT00597909 is a clinical study titled "Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy". The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

What is the current status of trial NCT00597909?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2007-12. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00597909?

The interventions under investigation include: sodium phenylacetate and sodium benzoate injection 10% / 10% (DRUG), placebo solution (10% dextrose) (DRUG).

Who is sponsoring clinical trial NCT00597909?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

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

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.