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NCT01265498 · ClinicalTrials.gov registry record · Phase 2
The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
A Phase 2 study of Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 283
- Enrollment target
- 9
- Study locations
NCT01265498 is a Phase 2 study of Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD) that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 283 participants, above the 81-participant average among 6 other Nonalcoholic Steatohepatitis (NASH) trials with a reported enrollment target (249% higher). The trial reports 9 study locations across 7 states.
The verdict
NCT01265498, a Phase 2 study of Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD), has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 283 participants
- Enrollment target
- 9
- Study locations
Study Summary
Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score (NAS).
Conditions Studied
Interventions
- DRUG placebo
- DRUG obeticholic acid
Study Locations (9)
California
- University of California, San Diego - San Diego
- University of California, San Francisco - San Francisco
Ohio
- Case Western Reserve University - Cleveland
- Cleveland Clinic Foundation - Cleveland
Indiana
- Indiana University - Indianapolis
Missouri
- St. Louis University - St Louis
North Carolina
- Duke University Medical Center - Durham
Virginia
- Virginia Commonwealth University - Richmond
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01265498
The ClinicalTrials.gov registry entry for NCT01265498 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 81-participant average among 6 other Nonalcoholic Steatohepatitis (NASH) trials with a reported enrollment target (249% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Nonalcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01265498 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, Ohio, Indiana.
Frequently Asked Questions
What is clinical trial NCT01265498 about?
NCT01265498 is a clinical study titled "The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)". Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the nonalcoholic fatty liver disease (NAFLD) activity score ...
What is the current status of trial NCT01265498?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 283 participants. The study started on 2011-03. Estimated completion is 2014-09.
What conditions does trial NCT01265498 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD).
What interventions are being tested in trial NCT01265498?
The interventions under investigation include: placebo (DRUG), obeticholic acid (DRUG).
Who is sponsoring clinical trial NCT01265498?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01265498 being conducted?
This trial has 9 study locations across California, Indiana, Missouri, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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