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NCT01966419 · ClinicalTrials.gov registry record · Phase 2

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

A Phase 2 study, sponsored by Ocera Therapeutics.

Completed
Registry status
Phase 2
Development phase
231
Enrollment target

NCT01966419 is a Phase 2 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 231 participants.

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The verdict

NCT01966419, a Phase 2 study, has completed, sponsored by Ocera Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
231 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

Interventions

  • DRUG placebo intravenous infusion
  • DRUG ornithine phenylacetate

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2014-01-07
Est. Completion 2016-12-29
Phase Phase 2

Sponsor

Ocera Therapeutics

9 total trials

What the Registry Record Tells You About NCT01966419

The ClinicalTrials.gov registry entry for NCT01966419 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocera Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo intravenous infusion is the first listed.

NCT01966419 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01966419 about?

NCT01966419 is a clinical study titled "Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)". The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

What is the current status of trial NCT01966419?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2014-01-07. Estimated completion is 2016-12-29.

What interventions are being tested in trial NCT01966419?

The interventions under investigation include: placebo intravenous infusion (DRUG), ornithine phenylacetate (DRUG).

Who is sponsoring clinical trial NCT01966419?

This trial is sponsored by Ocera Therapeutics, which has 9 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.