Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Cholic Acid for Hepatic Steatosis in Lipodystrophy
NCT00457639Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2006
- Primary completion
- Apr 2011
- Countries
- 1
- Sponsor
- UT Southwestern Medical Center
- Modality
- Small Molecules
- Drugs
- cholic acid
- Conditions
- hepatic steatosis
01
Overview
Phase 2, randomised, double-blind trial of cholic acid in hepatic steatosis (2 arms), sponsored by UT Southwestern Medical Center. Primary endpoint: Hepatic Triglyceride Content at 6 months. Started Apr 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence A (Cholic Acid -> Placebo)
Patients receive Cholic Acid in Period 1 and Placebo in Period 2
Sequence B (Placebo -> Cholic Acid)
Patients receive Placebo in Period 1 and Cholic Acid in Period 2
03
Who it enrols
Patients aged 6-70 with lipodystrophy and hepatic steatosis (>5.6% liver fat), excluding those with other liver diseases, HIV, or recent use of steatosis-modifying drugs.
04
Endpoints
Primary
Hepatic Triglyceride Content
Secondary
Serum Triglycerides
Beyond the preview
Go deeper on NCT00457639.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00457639.