Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial

Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial - Switching from entecavir to tenofovir for CHB patients with sustained viral supression

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018406

Enrollment

100

Registered

2015-07-24

Start date

2015-08-01

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

chronic hepatitis B

Interventions

Tenofovir disoproxil fumarate 300mg/day daily treatment period: 3 yaers Entecavir 0.5mg/day daily treatment period: 3 yaers

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients treated with entecavir for more than one year Inclusion criteria as following; 1) Hepatits B surface antigen positive 2) HBV DNA levels < 3.0 log copies/mL for more than one year 3) Absence of renal impairment (serum creatinine levels <1.1mg/dL, eGFR >60 ml/min/1.73m2 and creatinine clearance >50ml/min) 4) Absence of hypophosphatemia (serum phosphate >2.8 mg/dL)

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity for tenofovir 2) Presence of renal impairment 3) Presence of hypophosphatemia 4) Poorly-controlled diabetes 5) Poorly-controlled hypertension 6) History of hepatocellular carcinoma 7) Ineligible patients by atending physician

Design outcomes

Primary

Measure	Time frame
Number of patients who achieve the reduction of hepatitis surface antigen more than 0.5 log IU/mL for three years	—

Secondary

Measure	Time frame
1) The rates of negativity of hepatitis B e antigen for three years 2) The rates of negativity of hepatitis B surface antigen and achieving below 100 IU/mL or 1000 IU/mL of hepatitis B surface antigen levels for three years Predictive factors of the reduction of hepatitis B surface antigen 3) The rates of viral breakthrough for three years 4) The chenges of serum creatinine and phosphate for three years	—

Measure

Time frame

1) The rates of negativity of hepatitis B e antigen for three years 2) The rates of negativity of hepatitis B surface antigen and achieving below 100 IU/mL or 1000 IU/mL of hepatitis B surface antigen levels for three years Predictive factors of the reduction of hepatitis B surface antigen 3) The rates of viral breakthrough for three years 4) The chenges of serum creatinine and phosphate for three years

—

Countries

Japan

Contacts

Public ContactTetsuya Hosaka

Toranomon Hospital Hepatology

hosa-p@toranomon.gr.jp044-877-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026