Chronic hepatitis B
Conditions
Interventions
entecavir plus branched-chain amino acids
entecavir alone2
Sponsors
Hiroshima liver study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection 2)albumin level 4.0 g/dl or less
Exclusion criteria
Exclusion criteria: 1) a history of allergy induced by nucleoside analog or exposure to nucleoside analogs 2) had a history of oral BCAA supplementation for 6 months or longer 3) Pregnant or lactating women and women who may be pregnant 4) had major complication of liver cirrhosis, such as HCC, variceal bleeding, hepatic encephalopathy or ascites requiring diuretics, 5) had other nonhepatic major diseases 6) Patients with other liver disease (e.g., hepatitis C virus, alchol) 7) Judged by investigator not to be appropriate for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change from baseline in mean serum HBV-DNA level at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| the change from baseline in mean serum HBV-DNA level at week 4 and 8 the change from baseline in mean serum albumin level, ALT level, total bilirubin level and total cholesterol level at week 12 Safety (moniterd clinical and laboratory evaluation) | — |
Countries
Japan
Contacts
Public ContactYoshiiku Kawakami
graduate school of biomedical science, Hiroshima university Department and medicine and molecular science
Outcome results
None listed