Status:
COMPLETED
Cholic Acid for Hepatic Steatosis in Lipodystrophy
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Hepatic Steatosis
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to develop insulin resistance and its associated metabolic complications such as dyslipidemia, d...
Eligibility Criteria
Inclusion
- 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
- 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 systemic or major illnesses other than liver disease, such as congestive heart failure, cerebrovascular disease, respiratory failure, renal failure (serum creatinine \>2 mg/dL), acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy, that could interfere with the trial and adequate follow up.
- Acute medical illnesses precluding participation in the studies.
- Known HIV-infected patient.
- Current substance abuse.
- Pregnant or lactating women.
- Hematocrit of less than 30%. - History of weight loss during past 3 months.
- Patients on bile acid binding resins, cholestyramine, colestipol, colesevelam.
- Hypersensitivity or intolerance to CA or any components of its formulation
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00457639
Start Date
April 1 2006
End Date
April 1 2011
Last Update
August 6 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9052