Patients with chronic hepatitis B using tenofovir disoproxil fumarate
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chronic HBV infection (HBsAg positive for more than 6 months) Serum ALT level greater than 60 U/L (men) or 38 U/L (women) and less than 10 times the upper limit of normal (ULN) at screening Estimated creatinine clearance (CLCr) above 50 mL/min
Exclusion criteria
Exclusion criteria: Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study Coinfection with HCV, HIV or HDV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of fractures Change in bone density before and after drug use Change in percentage of patients with T-score below -2.5 before and after drug use | — |
Countries
Japan
Contacts
Hyogo Medical University School of Pharmacy