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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2014-01-07 |
| Est. Completion | 2016-12-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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