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NCT02786836 · ClinicalTrials.gov registry record · Phase 2
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT02786836: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT02786836 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02786836, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria. Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate). The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed. Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.
Primary Outcome
Peak PDR is the maximal percent dose recovery (PDR) rate which reflects the maximum rate of metabolism of 13C-methacetin measured as the change in 13CO2 / 12CO2 (normal carbon dioxide) ratio after ingestion of 13C-methacetin normalized using the patient's height and weight. The distributions of mean PDR Peak values were compared between TFS (transplant free survival) and non-TFS (death/transplant) at Day 21.
Interventions
- DRUG 13C-Methacetin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2016-06-10 |
| Est. Completion | 2019-09-18 |
| Phase | Phase 2 |
What the finished NCT02786836 record still lists
NCT02786836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which 13C-Methacetin is the first listed.
NCT02786836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02786836 about?
NCT02786836 is a clinical study titled "13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF". The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not ...
What is the current status of trial NCT02786836?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2016-06-10. Estimated completion is 2019-09-18.
What interventions are being tested in trial NCT02786836?
The interventions under investigation include: 13C-Methacetin (DRUG).
Who is sponsoring clinical trial NCT02786836?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02786836's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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
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