Comparative study between Entecavir and Tenofovir in the treatment of chronic hepatitis B infection in Thai patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20180626002

Enrollment

Unknown

Registered

2018-06-26

Start date

2010-10-05

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Chronic hepatitis B infection Chronic hepatitis B&#44

Interventions

Tenofovir 300 mg/day for 5 years,Entecavir 0.5 mg/day for 5 years

Experimental Drug,Active Comparator Drug

Tenofovir ,Entecavir

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chronic hepatitis B patients who had indication to receive antiviral treatment

Exclusion criteria

Exclusion criteria: 1 History of malignancy except early stage skin cancer 2 Decompensated cirrhosis 3 Creatinine clearance less than 50 ml/min 4 Kanofsky performance status less than 60 5 Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Efficacy year 1, 2, 3, 4 and 5 HBsAg loss, HBeAg loss, HBeAg seroconversion, HBV DNA suppression,HCC during study period Ultrasound	—

Secondary

Measure	Time frame
Safety every 6 month Creatinine, Phosphate	—

Countries

Thailand

Contacts

Public ContactTeerapat Ungtrakul

Chulabhorn Hospital

teerapat.ung@pccms.ac.th025766000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026