Hepatic Steatosis Clinical Trial
Official title:
Phase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy Patients
NCT number | NCT00457639 |
Other study ID # | 3085 |
Secondary ID | FD003085 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2006 |
Est. completion date | April 2011 |
Verified date | January 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 70 Years |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | FDA Office of Orphan Products Development |
United States,
Ahmad Z, Subramanyam L, Szczepaniak L, Simha V, Adams-Huet B, Garg A. Cholic acid for hepatic steatosis in patients with lipodystrophy: a randomized, controlled trial. Eur J Endocrinol. 2013 Apr 15;168(5):771-8. doi: 10.1530/EJE-12-0969. Print 2013 May. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatic Triglyceride (%) | Measured by proton magnetic resonance spectroscopy (MRS) | 6 months | |
Secondary | Serum Triglycerides | Months 6 |
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