Hyperuricemia and Non-Alcoholic Steatohepatitis
Conditions
Interventions
Febuxostat 10mg per day will be given to the patients as the first dose, and then it can be increased to 20mg and 40mg per day every 4 week. The maintenance dose should be 40mg per day, however, it ca
Sponsors
Kanazawa University Graduate School of Medical Science, Disease Control and Homeostasis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Serum uric acid; more than 7.0 mg/dl 2. Diagnosed as NASH by imaging studies or histological test(The histological test should be done within 5 years before entry of this study.) 3. Serum ALT; greater than or equal to 31 IU/L 4. Tolerable to take Febuxostat for at least 6 months 5. Child-Pugh classification A 6. Age older than or equal to 20 years old at the entry 7. Performance status (ECOG scale) 0 or 1 8. The function of main organs should be well maintained within 30 days before entry. 1. WBC; greater than or equal to 3000 and less than 12000 /ul 2. Hb; greater than or equal to 9.0g/dL 3. Platelet; greater than or equal to 70000 /ul 4. Total Bilirubin; less than or equal to 1.5 mg/dL or lower than upper limit of the clinic 5. Serum Cr; less than or equal to1.5 mg/dL 6. Serum ALT; greater than or equal to 31 and less than 200 U/L 9. The patients have to agree to join this study by their free wills after being well explained about this study. 10. Outpatient
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of serum ALT after taking Febuxostat for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTetsuro Shimakami
Kanazawa University Hospital Department of Gastroenterology
Outcome results
None listed