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NCT02084160 · ClinicalTrials.gov registry record
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
A clinical trial, sponsored by Meridian Bioscience.
- Completed
- Registry status
- 579
- Enrollment target
NCT02084160: Completed study, sponsored by Meridian Bioscience.
NCT02084160 is a clinical trial that has completed, run by Meridian Bioscience. The registered enrollment target is 579 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02084160 has completed, sponsored by Meridian Bioscience.
- COMPLETED
- Registry status
- 579 participants
- Enrollment target
Study Summary
The objectives of this study are: * To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events * To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy. * To evaluate the ability of the MBT to predict each of the individual liver related complications.
Primary Outcome
Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: 1. Death (liver related) 2. Transplantation (cadaveric and living donors) 3. Ascites 4. HE (Hepatic Encephalopathy) 5. Newly diagnosed varices or variceal bleeding 6. SBP (spontaneous bacterial peritonitis) 7. HRS (Hepatorenal syndrome) 8. HCC (hepatocellular carcinoma) 9. Increase in CTP (Child Turcotte P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-11 |
What the finished NCT02084160 record still lists
NCT02084160 is an observational study that tracks outcomes without assigning an intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02084160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02084160 about?
NCT02084160 is a clinical study titled "Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation". The objectives of this study are: * To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events * To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biops...
What is the current status of trial NCT02084160?
This trial is currently completed. The enrollment target is 579 participants. The study started on 2014-03. Estimated completion is 2018-11.
Who is sponsoring clinical trial NCT02084160?
This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.
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