Trial · NCT01599286
Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia
NCT01599286, Phase 2, Completed, Mendel Tuchman; results first posted 2021-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia. Trials, record NCT01599286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01599286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia
- NCT number
- NCT01599286
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Mendel Tuchman
- Conditions
- Propionic Acidemia, Type I and/or Type II, Methylmalonic Acidemia, Carbamoyl-Phosphate Synthase I Deficiency Disease, Ornithine Carbamoyltransferase Deficiency
- Interventions
- Carbaglu, Placebo
- First posted
- 2012-05-16
- Last updated
- 2021-02-15
- Results first posted
- 2021-02-15
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) | Average of all measurements of hyperammonemia, for up to 7 days | The composite primary intention to treat (ITT) outcome of the earlier of time to reach an ammonia level of ≤50 µmol/L or hospital discharge. Data presented as a hazard ratio based on the time to reach an ammonia level of ≤50 µmol/L. The outcome measure was a survival analysis based on time to reach the earlier of an ammonia level of ≤50 µmol/L or time to discharge, which was considered to be a point where the patient was no longer at risk of neurological injury from ammonia. The outcome of survival analysis was a hazard ratio reflecting the ratio of probabilities in each group (drug vs placebo) of reaching the earlier of an ammonia level of ≤50 µmol/L or discharge. We measured multiple post-treatment ammonia levels at uncontrolled times during an episode, so it is difficult to compute a meaningful average that would not be biased by the frequency and timing of ammonia testing during episodes. |
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 | Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) | Average of all measurements of hyperammonemia, for up to 7 days | Patients were randomized to either study drug or placebo at each episode of hyperammonemia analysed by diagnosis. Data presented as a hazard ratio based on the time to reach an ammonia level of ≤50 µmol/L. Higher ratios reflect an NCG advantage. | Hazard Ratio | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) | PA/MMA Episodes | 1.37 | 95% Confidence Interval 0.88 to 2.13 | Hazard Ratio | |
| Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) | CPS1D/OTCD Episodes | 0.79 | 95% Confidence Interval 0.22 to 2.81 | Hazard Ratio |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Episodes of N-Carbamylglutamate | 24 | 54 |
| Overall Study | STARTED | Episodes of Placebo | 23 | 52 |
| Overall Study | COMPLETED | Episodes of N-Carbamylglutamate | 24 | 54 |
| Overall Study | COMPLETED | Episodes of Placebo | 23 | 52 |
| Overall Study | NOT COMPLETED | Episodes of N-Carbamylglutamate | 0 | 0 |
| Overall Study | NOT COMPLETED | Episodes of Placebo | 0 | 0 |
Source ClinicalTrials.gov
Adverse events38
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 | Blood/Lymphatic | Blood and lymphatic system disorders | Placebo | 3 | 24 | 4 |
| other | Blood/Lymphatic | Blood and lymphatic system disorders | N-carbamylglutamate (NCG) | 4 | 25 | 6 |
| other | Cardiac | Cardiac disorders | Placebo | 1 | 24 | 1 |
| other | Cardiac | Cardiac disorders | N-carbamylglutamate (NCG) | 1 | 25 | 1 |
| other | Gastrointestinal | Gastrointestinal disorders | Placebo | 4 | 24 | 9 |
| other | Gastrointestinal | Gastrointestinal disorders | N-carbamylglutamate (NCG) | 4 | 25 | 8 |
| other | General | General disorders | Placebo | 3 | 24 | 5 |
| other | General | General disorders | N-carbamylglutamate (NCG) | 1 | 25 | 2 |
| other | Infections | Infections and infestations | Placebo | 3 | 24 | 4 |
| other | Infections | Infections and infestations | N-carbamylglutamate (NCG) | 1 | 25 | 1 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 10 | 24 |
| Total, all-cause mortality | N-carbamylglutamate (NCG) | 14 | 25 |
| Total, other adverse events | Placebo | 9 | 24 |
| Total, other adverse events | N-carbamylglutamate (NCG) | 11 | 25 |
| Total, serious adverse events | Placebo | 6 | 24 |
| Total, serious adverse events | N-carbamylglutamate (NCG) | 8 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33006765 | DERIVED |
Source PubMed
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 |
|---|---|
| N-carbamylglutamate (NCG) vs Placebo: deaths from any cause | Trial comparisons |
| N-carbamylglutamate (NCG) 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/NCT01599286
GET https://conductscience.org/api/trials/v1/NCT01599286/events?page=2