Comparative study between Entecavir and Tenofovir in the treatment of chronic hepatitis B infection in Thai patients
Phase 3
Completed
- Conditions
- Chronic hepatitis B infectionChronic hepatitis B,Tenofovir,Entecavir,Efficacy,Safety
- Registration Number
- TCTR20180626002
- Lead Sponsor
- Chulabhorn Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 442
Inclusion Criteria
1. Chronic hepatitis B patients who had indication to receive antiviral treatment
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy year 1, 2, 3, 4 and 5 HBsAg loss, HBeAg loss, HBeAg seroconversion, HBV DNA suppression,HCC during study period Ultrasound
- Secondary Outcome Measures
Name Time Method Safety every 6 month Creatinine, Phosphate