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NCT01244503 · ClinicalTrials.gov registry record · Phase 2
Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
A Phase 2 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT01244503: Clinical Trial Phase 2 study, sponsored by Virginia Commonwealth University.
NCT01244503 is a Phase 2 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244503, a Phase 2 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH with a high probability.
Primary Outcome
To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose re
Interventions
- DRUG Sodium Octanoate Breath Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
Why NCT01244503 stopped before completion
NCT01244503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Octanoate Breath Test is the first listed.
NCT01244503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01244503 about?
NCT01244503 is a clinical study titled "Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)". The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH with a high probability.
What is the current status of trial NCT01244503?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2011-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01244503?
The interventions under investigation include: Sodium Octanoate Breath Test (DRUG).
Who is sponsoring clinical trial NCT01244503?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01244503's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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