chronic HBV infection
Conditions
Interventions
Switch to tenofovir 300 mg/day in patients treated with entecavir 0.5 mg/day and observe for 2 years
Continue entecavir 0.5 mg/day in patients treated with entecavir and observe for 2 years
Switch to
Sponsors
Tohoku University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with chronic HBV infection who have been treated with entecavir or combination of adefovir and lamivudine for more than 1 year (2) HBV DNA is less than 4.0 log copies/ml (3) The liver disease is chronic hepatitis or compensated liver cirrhosis (up to Clid-Pugh grade A)
Exclusion criteria
Exclusion criteria: (1) Patients who is received interferon treatments (2) Patients who is taking immunosuppressive agents (3) Patients who have present or past hepatocellular carcinoma, or other malignant diseases (4) Patients who have decompensated liver cirrhosis (5) Patients who have renal dysfunction (eGFR is less than 50 ml/min/1.72m2) (6) Patients who have low serum phosphorus (less than 2.5 mg/dl) (7) Patients who are pregnant or have possibility of pregnancy (8) Breast-feeding patients (9) Patients who is infected also with HIV or HCV (10) Patients who is participating other studies (11) Patients who is considered inappropriate for this study by doctors in attendance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decline of HBsAg 2 years after the enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| The negativity of HBV DNA and HBeAg, and the normalization of ALT | — |
Countries
Japan
Contacts
Public ContactEiji Kakazu
Tohoku University Hospital Division of Gastroenterology
Outcome results
None listed