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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 Non-alcoholic Steatohepatitis (NASH) and Non-Alcoholic 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: Completed Phase 2 study of Non-alcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01265498 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) and Non-Alcoholic 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 179-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (58% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01265498, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) and Non-Alcoholic 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).
Primary Outcome
Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as: 1. No worsening in fibrosis; and 2. A decrease in NAFLD Activity Score (NAS) of at least 2 points
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 |
What the finished NCT01265498 record still lists
NCT01265498 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (58% higher).
The record links to 2 conditions, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01265498 lists 9 locations in 7 states (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: Non-alcoholic Steatohepatitis (NASH), Non-Alcoholic 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.
Learn More About Clinical Trials
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Where NCT01265498's enrollment target sits among peer trials
283 2nd of 16 the highest of 16 other Non-alcoholic Steatohepatitis (NASH) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Steatohepatitis (NASH) 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.
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