Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy

Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy - Compare the value of increased dose to combination therapy with nucleoside analogues

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003982

Enrollment

Registered

2010-08-03

Start date

2010-08-01

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

Entecavir 0.5mg/day + Adefovir 10mg/day Entecavir 1.0mg/day Entecavir 0.5mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic hepatitis B Entecavir 0.5mg/day HBV DNA positive HBcrAg >=4.0 Log IU/ml HBsAg >=1000IU/ml

Exclusion criteria

Exclusion criteria: 1. Resistant to Entecavir 2. Intolerance to Entecavir 3. Pregnant, lactating women 4. Possibly pregnant women 5. Chronic kidney failure 6. Creatinine clearance of <=50 mL/ min 7. Severe heart diseases 8. Decompensated liver cirrhosis 9. Liver transplant patient 10. HIV/HBV superinfection

Design outcomes

Primary

Measure	Time frame
Improvement of HBcrAg, HBsAg	—

Secondary

Measure	Time frame
safety	—

Countries

Japan

Contacts

Public ContactMasaki Saito

Hyogo College Of Medicine Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine

he-jishu@hyo-med.ac.jp0798-45-6472

Outcome results

None listed

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