Efficacy and safety of tenofovir disoproxil fumarete (TDF) in nucleos(t)ide analogue-naive patients with hepatitis B virus

Efficacy and safety of tenofovir disoproxil fumarete (TDF) in nucleos(t)ide analogue-naive patients with hepatitis B virus - Efficacy and safety of tenofovir disoproxil fumarete (TDF)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017728

Enrollment

200

Registered

2015-06-01

Start date

2015-04-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic hepatitis B virus infection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with 20 years of age and older 2) HB surface antigen positive for over 6 months

Exclusion criteria

Exclusion criteria: 1) pregnant woman 2) co-infection with other hepatitis virus (HCV/HDV/HIV) 3) contraindication to tenofovir disoploxil fumarate

Design outcomes

Primary

Measure	Time frame
probability of HBV DNA negativity dicrease rate of HB surface antigen level dicrease rate of HB core-related antigen probability of HBe antigen seroconversion probability of ALT normalization cumulative incidence rate of hepatocellular carcinoma	—

Countries

Japan

Contacts

Public ContactRyoko Yamada

Osaka University Graduate School of Medicine Gastroenterology and Hepatology

ryo726@gh.med.osaka-u.ac.jp81-6-6879-3621

Outcome results