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NCT01200082 · ClinicalTrials.gov registry record
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
A clinical trial, sponsored by University of Nebraska.
- Terminated
- Registry status
- 430
- Enrollment target
NCT01200082: Clinical Trial study, sponsored by University of Nebraska.
NCT01200082 is a clinical trial that was terminated before completion, run by University of Nebraska. The registered enrollment target is 430 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200082 was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- 430 participants
- Enrollment target
Study Summary
The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases. The investigators rationale in this project is that the discovery of biomarkers specific to liver injury would provide the foundation for a specific and non-invasive tool to evaluate disease prognosis, determine patients with higher risk of developing end-stage liver diseases, and determine patients with higher risk of recurrence of hepatobiliary complications after liver transplant. Patients on the liver transplant list are continuously monitored during their hospitalization and are scheduled for follow-up visits for 12 months after their release post-surgery. Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver transplant, and incidence of complications related to hepatobiliary conditions such as fluid retention, GI bleeding, encephalopathy, and biliary stricture complications.
Primary Outcome
Bile acids (BAs), the end products of cholesterol metabolism, are synthesized in liver and excreted into bile, which flows to the small intestine via the bile duct. Most of the BAs are reabsorbed from the intestine into the portal circulation and undergo enterohepatic recirculation with minimal levels detected in urine and blood under normal conditions.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2011-11 |
| Est. Completion | 2022-09-02 |
Why NCT01200082 stopped before completion
NCT01200082 is an observational study that tracks outcomes without assigning an intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01200082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01200082 about?
NCT01200082 is a clinical study titled "Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases". The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases. The investigators rationale in this project is that the discovery of biomarkers specific to liver injury w...
What is the current status of trial NCT01200082?
This trial is currently terminated. The enrollment target is 430 participants. The study started on 2011-11. Estimated completion is 2022-09-02.
Who is sponsoring clinical trial NCT01200082?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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