Cholic Acid for Hepatic Steatosis in Lipodystrophy (NCT00457639) | Clinical Trial Compass
CompletedPhase 2
Cholic Acid for Hepatic Steatosis in Lipodystrophy
United States18 participantsStarted 2006-04
Plain-language summary
To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.
Who can participate
Age range6 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients with lipodystrophies as diagnosed by clinical criteria.
* Hepatic steatosis (\>5.6% hepatic triglyceride content) as demonstrated by 1H magnetic resonance spectroscopy.
* Age 6-70 years.
* Alcohol intake of less than 40 g per week.
Exclusion Criteria:
* Laboratory or other histologic findings highly suggestive of liver disease due to causes other than non-alcoholic steatohepatitis, such as chronic viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction or genetic liver diseases such as Wilson's disease, hemochromatosis or alpha-1-antitrypsin deficiency.
* Treatment with drugs associated with steatohepatitis, e.g., corticosteroids, high dose estrogens, methotrexate, amiodarone, , sulfasalazine, or oxacillin in the 6 months prior to the study.
* Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time, hypoalbuminemia, presence of esophageal varices etc.)
* Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer.
* Use of drugs which can potentially decrease hepatic steatosis during previous 3 months; ursodeoxycholic acid, high-dose vitamin E, betaine, acetylcysteine and choline. Thiazolidinediones are allowed if dose has been stable for 3 months prior to screening.
* Significant systemi…
What they're measuring
1
Hepatic Triglyceride (%)
Timeframe: 6 months
Trial details
NCT IDNCT00457639
SponsorUniversity of Texas Southwestern Medical Center