Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00794716 · ClinicalTrials.gov registry record · Phase 2
PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study, sponsored by Norgine.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT00794716 is a Phase 2 study that has completed, run by Norgine. The registered enrollment target is 125 participants.
The verdict
NCT00794716, a Phase 2 study, has completed, sponsored by Norgine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.
Interventions
- DRUG NRL972
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00794716
The ClinicalTrials.gov registry entry for NCT00794716 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Norgine, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NRL972 is the first listed.
NCT00794716 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00794716 about?
NCT00794716 is a clinical study titled "PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)". This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard ...
What is the current status of trial NCT00794716?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2008-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00794716?
The interventions under investigation include: NRL972 (DRUG).
Who is sponsoring clinical trial NCT00794716?
This trial is sponsored by Norgine, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.