Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Ocera Therapeutics.
NCT01966419 is a Phase 2 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 231 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse. The stages are described as: Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Parti
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 |
What the finished NCT01966419 record still lists
NCT01966419 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo intravenous infusion is the first listed.
NCT01966419 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01966419's enrollment target sits among peer trials
231 257th of 2000 higher than 1,744 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04077099 · 231 participants · Phase 1
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
- NCT05019495 · 231 participants · NA
Optimizing Tobacco Treatment Delivery for People Living With HIV
- NCT06023589 · 231 participants · Phase 3
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
- NCT06734351 · 231 participants · Phase 3
A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI