HCV related chronic liver disease except for decompensated cirrhosis
Conditions
Interventions
4 g BCAA preparation containing 952 mg l-isoleucine, 1904 mg l-leucine, and 1144 mg l-valine (LIVACT Granules&
reg
Ajinomoto Co., Inc., Tokyo) administered orally three times daily after meals and dietary therapy for four years
dietary therapy
Sponsors
Keio University,Division of Gastroenterology,Department of Internal Medicine
KITASATO INSTITUTEHOSPITAL SAISEIKAI CENTRAL HOSPITAL NIHON KOKAN HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who has HCV-RNA positive and diagnosed HCV related chronic liver disease. 2) Patient whose serum albumin level is less than 3.9g/dl. 3) Patient whose age is more than twenty. 4) Patient who gives written informed concent.
Exclusion criteria
Exclusion criteria: 1) Patient whose serum total bilirubin level is more than 2.0 mg/dl. 2) Patient whose serum creatinine level is more than 2.1 mg/dl. 3) Patient who has hepatocellular carcinoma. 4) Patient who has ascites. 5) Patient who has edema. 6) Patient who has hepatic encephalopathy. 7) Patient who has esophageal varices requiring treatment or treatment history. 8) Patient who is heavy drinker 9) Patient who has diabetes requiring treatment 10) Patients who is in pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of hepatocellular carcinoma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) incidence of the ascites 2) incidence of the edema 3) incidence of the hepatic encephalopathy 4) incidence of jaundice 5) progress of the esophageal or gastric varices 6) transition of the glucose metabolic marker | — |
Countries
Japan
Contacts
Public ContactNaoki Hosoe
Keio University Division of Gastroenterology,Department of Internal Medicine
Outcome results
None listed