Trial · NCT01966419
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
NCT01966419, Phase 2, Completed, Ocera Therapeutics, Inc.; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE). Trials, record NCT01966419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01966419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
- NCT number
- NCT01966419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 231 participants, actual
- Lead sponsor
- Ocera Therapeutics, Inc.
- Conditions
- Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
- Interventions
- ornithine phenylacetate, placebo intravenous infusion
- First posted
- 2013-10-21
- Last updated
- 2021-09-16
- Other registries' IDs
- eudract:2013-005412-10
- Results first posted
- 2021-09-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Each HE Stage | Baseline to End of Study (through 3 hours post end-of-infusion) | 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 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Each HE Stage | Baseline to End of Study (through 3 hours post end-of-infusion) | Intention to Treat Analysis Set (Note: all participants did not start at the same time) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Each HE Stage | Placebo | Baseline : Stage 4 | 11 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Ornithine Phenylacetate | Baseline : Stage 4 | 6 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Placebo | Baseline : Stage 3 | 30 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Ornithine Phenylacetate | Baseline : Stage 3 | 40 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Placebo | Baseline : Stage 2 | 71 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Ornithine Phenylacetate | Baseline : Stage 2 | 68 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Placebo | Baseline : Stage 0/1 | 0 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Ornithine Phenylacetate | Baseline : Stage 0/1 | 0 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Placebo | Baseline : Missing | 3 | percentage of participants | |
| Percentage of Participants in Each HE Stage | Ornithine Phenylacetate | Baseline : Missing | 2 | percentage of participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 115 | |
| Overall Study | STARTED | Ornithine Phenylacetate | 116 | |
| Overall Study | Intent to Treat Population (ITT)T)115 | Placebo | 115 | |
| Overall Study | Intent to Treat Population (ITT)T)115 | Ornithine Phenylacetate | 116 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 112 | |
| Overall Study | Safety Analysis Set (SAS) | Ornithine Phenylacetate | 114 | |
| Overall Study | COMPLETED | Placebo | 74 | |
| Overall Study | COMPLETED | Ornithine Phenylacetate | 80 | |
| Overall Study | NOT COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Ornithine Phenylacetate | 36 |
Source ClinicalTrials.gov
Adverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 8 | 112 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Ornithine Phenylacetate | 13 | 114 | 14 |
| other | Pyrexia | General disorders | Placebo | 7 | 112 | 7 |
| other | Pyrexia | General disorders | Ornithine Phenylacetate | 6 | 114 | 6 |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 112 | 4 |
| other | Urinary tract infection | Infections and infestations | Ornithine Phenylacetate | 8 | 114 | 8 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 8 | 112 | 10 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Ornithine Phenylacetate | 9 | 114 | 9 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Placebo | 9 | 112 | 9 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Ornithine Phenylacetate | 5 | 114 | 5 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 15 | 112 |
| Total, all-cause mortality | Ornithine Phenylacetate | 11 | 114 |
| Total, other adverse events | Placebo | 31 | 112 |
| Total, other adverse events | Ornithine Phenylacetate | 30 | 114 |
| Total, serious adverse events | Placebo | 34 | 112 |
| Total, serious adverse events | Ornithine Phenylacetate | 29 | 114 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ornithine Phenylacetate vs Placebo: deaths from any cause | Trial comparisons |
| Ornithine Phenylacetate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01966419
GET https://conductscience.org/api/trials/v1/NCT01966419/results?page=2