The Effect of Febuxostat on the Patient with Hyperuricemia and Non-alcoholic Steatohepatitis
- Conditions
- Hyperuricemia and Non-Alcoholic Steatohepatitis
- Registration Number
- JPRN-UMIN000008686
- Lead Sponsor
- Kanazawa University Graduate School of Medical Science, Disease Control and Homeostasis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Not provided
The following patients should be excluded; 1. Infected with HBV or HCV 2. Alcohol assumption per day; greater than or equal to 30g for male, 20g/day for female 3. Accompanied with obvious malignant diseases including hepatoma 4. Accompanied with obvious hepatic encephalopathy 5. Accompanied with active infectious diseases (body temperature; higher or equal to 38 degree) 6.Accompanied with severe complications such as paralysis of intestine, ileus, interstitial pneumonia, pulmonary fibrosis, poorly controlled diabetes mellitus, heart failure, renal failure, liver failure, active ulcer and risky varix of digestive tract, and severe mental disturbance or depression etc. 7. Nursing woman and pregnant woman or the woman who may be pregnant 8. Taking contraindicating medicines with Febuxostat, such as mercaptopurine-hydrate, azathioprine, vidarabine, or didanosine. 9. Taking the following medicines which could affect serum uric acid within 4 weeks before considering entry of this study; losartan, fenofibrate, loop diuretic, or thiazide diuretic. 10. Taking the following uric acid-lowering medicines within 4 weeks before considering entry of this study; allopurinol, benzbromarone, probenecid, bucolome, or febuxostat. 11. Taking salicylated medicines everyday, however, the patients taking low dose of aspirin salicylate (less than or equal to 324 mg/day) cannot be excluded. 12.Taking estrogenic hormone everyday. 13. The other patients who the doctors in charge consider should not enter this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of serum ALT after taking Febuxostat for 6 months
- Secondary Outcome Measures
Name Time Method The following are assessed after taking Febuxostat for 6 months; 1. Safety 2. Improvement of fatty liver by CT 3. Improvement of histological findings of liver 4. The effect of Febuxostat on serum uric acid, liver function except for ALT, renal function, lipid and glucose metabolism, cytokines, and oxidative-stress marker. 5. The effect of Febuxostat on the gene expression related to uric metabolism and glucose metabolism in blood and liver