Trial · NCT00597909
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
NCT00597909, Phase 2, Terminated, Amgen; results first posted 2016-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy. Trials, record NCT00597909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
- NCT number
- NCT00597909
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hepatic Encephalopathy
- Interventions
- sodium phenylacetate and sodium benzoate injection 10% / 10%, sodium phenylacetate and sodium benzoate injection 10% / 10%, placebo solution (10% dextrose)
- First posted
- 2008-01-18
- Last updated
- 2024-12-17
- Results first posted
- 2016-03-31
- Limitations and caveats
- One participant was enrolled but did not receive drug or was randomized.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer | Time to Grade 2 or less sustaining for 4 hours or longer | |
| Secondary | Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results | 96 hours of treatment and follow-up | |
| Secondary | Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria | 96 hours of treatment and follow-up | |
| Secondary | Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria | 96 hours of treatment and follow-up | |
| Secondary | Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria | 96 hours of treatment and follow-up | |
| Secondary | Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria | participants will be followed for the duration of hospital stay, an expected average of 96 hours | |
| Secondary | Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale | 96 hours of treatment and follow-up | |
| Secondary | Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine | 96 hours of treatment and follow-up | |
| Secondary | Pharmacokinetic Characteristics of Ammonul® and Its Metabolites | Every 24 hours during treatment period of 96 hours |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer | Time to Grade 2 or less sustaining for 4 hours or longer | One participant enrolled but did not receive drug or was randomized. | ||
| SECONDARY | Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results | 96 hours of treatment and follow-up | |||
| SECONDARY | Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria | 96 hours of treatment and follow-up | |||
| SECONDARY | Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria | 96 hours of treatment and follow-up | |||
| SECONDARY | Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria | 96 hours of treatment and follow-up | |||
| SECONDARY | Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria | participants will be followed for the duration of hospital stay, an expected average of 96 hours | |||
| SECONDARY | Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale | 96 hours of treatment and follow-up | |||
| SECONDARY | Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine | 96 hours of treatment and follow-up | |||
| SECONDARY | Pharmacokinetic Characteristics of Ammonul® and Its Metabolites | Every 24 hours during treatment period of 96 hours |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 0 | |
| Overall Study | STARTED | Arm 2 | 0 | |
| Overall Study | STARTED | Arm 3 | 0 | |
| Overall Study | COMPLETED | Arm 1 | 0 | |
| Overall Study | COMPLETED | Arm 2 | 0 | |
| Overall Study | COMPLETED | Arm 3 | 0 | |
| Overall Study | NOT COMPLETED | Arm 1 | 0 | |
| Overall Study | NOT COMPLETED | Arm 2 | 0 | |
| Overall Study | NOT COMPLETED | Arm 3 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, all-cause mortality | Arm 3 | ||
| Total, other adverse events | Arm 1 | 0 | 0 |
| Total, other adverse events | Arm 2 | 0 | 0 |
| Total, other adverse events | Arm 3 | 0 | 0 |
| Total, serious adverse events | Arm 1 | 0 | 0 |
| Total, serious adverse events | Arm 2 | 0 | 0 |
| Total, serious adverse events | Arm 3 | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT00597909
GET https://conductscience.org/api/trials/v1/NCT00597909/registered