Trial · NCT01548690
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
NCT01548690, Phase 2, Completed, William Lee; results first posted 2018-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury. Trials, record NCT01548690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01548690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
- NCT number
- NCT01548690
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- William Lee
- Conditions
- Acute Liver Failure, Acute Liver Injury
- Interventions
- Ornithine Phenylacetate
- First posted
- 2012-03-08
- Last updated
- 2018-10-30
- Results first posted
- 2018-09-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | 30 Days | To evaluate the safety and tolerability of OCR-002 in patients with acute liver failure/severe acute liver injury |
| Secondary | Measurement of OCR-002 Plasma Concentration | 24 Hours after last infusion | To evaluate the steady state pharmacokinetic and pharmacodynamic profile of OCR-002 in patients with impaired and intact renal function using urinary phenylacetylglutamine (PAGN) as a surrogate marker |
| Secondary | Change in Ammonia | Baseline and 72 Hours | To evaluate the effect of OCR-002 on ammonia levels in patients with acute liver failure/severe acute liver injury |
| Secondary | Neurological Function Measured by the West Haven Criteria (WHC) for Hepatic Encephalopathy | 120 hours from start of infusion | The West Haven Criteria (WHC) for Hepatic Encephalopathy measures the severity of encephalopathy and patient's level of consciousness. The scale ranges from 0 to 4; a minimum score of 0 represents a better outcome, and a maximum total score of 4 represents a worse outcome. A score of 0 corresponds to normal consciousness and behavior and normal neurological examination. A score of 1 corresponds to mild lack of awareness, shortened attention span, and impaired addition or subtraction; mild asterixis or tremor. A score of 2 corresponds to lethargy, disorientated or inappropriate behavior, obvious asterixis; slurred speech. A score of 3 corresponds to somnolent but arousable, gross disorientation or bizarre behavior, muscle rigidity and clonus; hyperreflexia. A score of 4 corresponds to coma and decerebrate posturing. |
| Secondary | Neurological Function Measured by the Orientation Log (O-log) | 30 Days | The orientation log focuses on orientation to place, time, and circumstance. There are 10 items on the orientation log, which are scored 0-3. A spontaneous correct response is awarded 3 points. A spontaneous response that is lacking or incorrect, but a correct response is provided following a logical cue is awarded 2 points. A score of 1 is given if spontaneous and cued responses are lacking or incorrect, but a correct response is provided in a recognition format. A score of 0 is given if the spontaneous, cued, or recognition format does not generate a correct answer. Scores from the 10 items are summed and the final score ranges from 0 to 30. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | 30 Days | All patients who consented to the study, completed screening and had the intravenous infusion of study drug initiated | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Measurement of OCR-002 Plasma Concentration | 24 Hours after last infusion | All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 120 hours and had results available from serum and urine samples measuring the pharmacokinetic (PK), pharmacodynamic profile (phenylacetic acid (PAA), ornithine) and urinary phenylacetylglutamine (PAGN) levels. | micrograms per millileter | MEAN |
| SECONDARY | Change in Ammonia | Baseline and 72 Hours | All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 72 hours and available venous or arterial ammonia levels. | Percent Change | MEAN |
| SECONDARY | Neurological Function Measured by the West Haven Criteria (WHC) for Hepatic Encephalopathy | 120 hours from start of infusion | All patients who consented to the study and had the intravenous infusion of study drug initiated and West Haven Criteria (WHC) for Hepatic Encephalopathy assessment scores available. | units on a scale | MEAN |
| SECONDARY | Neurological Function Measured by the Orientation Log (O-log) | 30 Days | All patients who consented to the study and had the intravenous infusion of study drug initiated and Orientation log (O-log) assessment scores available. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Maximum Dose Level 3.33 g/24h | 0 | Participants | ||
| Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Maximum Dose Level 6.65 g/24h | 0 | Participants | ||
| Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Maximum Dose Level 10 g/24h | 0 | Participants | ||
| Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | Maximum Dose Level 20g/24h | 0 | Participants | ||
| Measurement of OCR-002 Plasma Concentration | Maximum Dose Level 3.33 g/24h | 65.6 | Standard Deviation 82.5 | micrograms per millileter | |
| Measurement of OCR-002 Plasma Concentration | Maximum Dose Level 6.65 g/24h | 32.2 | Standard Deviation 31.4 | micrograms per millileter | |
| Measurement of OCR-002 Plasma Concentration | Maximum Dose Level 10 g/24h | 33.4 | Standard Deviation 24.1 | micrograms per millileter | |
| Measurement of OCR-002 Plasma Concentration | Maximum Dose Level 20g/24h | 104.9 | Standard Deviation 104.5 | micrograms per millileter | |
| Change in Ammonia | Maximum Dose Level 3.33 g/24h | 41.2 | Standard Deviation 21.1 | Percent Change | |
| Change in Ammonia | Maximum Dose Level 6.65 g/24h | 16.6 | Standard Deviation 51.4 | Percent Change |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maximum Dose Level 3.33 g/24h | 9 | |
| Overall Study | STARTED | Maximum Dose Level 6.65 g/24h | 10 | |
| Overall Study | STARTED | Maximum Dose Level 10 g/24h | 13 | |
| Overall Study | STARTED | Maximum Dose Level 20g/24h | 15 | |
| Overall Study | Evaluable (72 Hours on Infusion) | Maximum Dose Level 3.33 g/24h | 6 | |
| Overall Study | Evaluable (72 Hours on Infusion) | Maximum Dose Level 6.65 g/24h | 6 | |
| Overall Study | Evaluable (72 Hours on Infusion) | Maximum Dose Level 10 g/24h | 12 | |
| Overall Study | Evaluable (72 Hours on Infusion) | Maximum Dose Level 20g/24h | 12 | |
| Overall Study | COMPLETED | Maximum Dose Level 3.33 g/24h | 9 | |
| Overall Study | COMPLETED | Maximum Dose Level 6.65 g/24h | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events232
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 | Abdominal distension | Gastrointestinal disorders | Maximum Dose Level 3.33 g/24h | 1 | 9 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Maximum Dose Level 6.65 g/24h | 0 | 10 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Maximum Dose Level 10 g/24h | 0 | 13 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Maximum Dose Level 20g/24h | 0 | 15 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Maximum Dose Level 3.33 g/24h | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Maximum Dose Level 6.65 g/24h | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Maximum Dose Level 10 g/24h | 0 | 13 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Maximum Dose Level 20g/24h | 1 | 15 | 2 |
| other | Alcohol withdrawal syndrome | General disorders | Maximum Dose Level 3.33 g/24h | 0 | 9 | 0 |
| other | Alcohol withdrawal syndrome | General disorders | Maximum Dose Level 6.65 g/24h | 0 | 10 | 0 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maximum Dose Level 3.33 g/24h | 2 | 9 |
| Total, all-cause mortality | Maximum Dose Level 6.65 g/24h | 3 | 10 |
| Total, all-cause mortality | Maximum Dose Level 10 g/24h | 2 | 13 |
| Total, all-cause mortality | Maximum Dose Level 20g/24h | 4 | 15 |
| Total, other adverse events | Maximum Dose Level 3.33 g/24h | 8 | 9 |
| Total, other adverse events | Maximum Dose Level 6.65 g/24h | 5 | 10 |
| Total, other adverse events | Maximum Dose Level 10 g/24h | 9 | 13 |
| Total, other adverse events | Maximum Dose Level 20g/24h | 7 | 15 |
| Total, serious adverse events | Maximum Dose Level 3.33 g/24h | 5 | 9 |
| Total, serious adverse events | Maximum Dose Level 6.65 g/24h | 3 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers33
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DK058369 | A Multi-Center Group to Study Acute Liver Failure | LEE, WILLIAM M; DURKALSKI, VALERIE L; FONTANA, ROBERT J; STRAVITZ, RICHARD | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2005 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01548690
GET https://conductscience.org/api/trials/v1/NCT01548690/events?page=2