An Efficacy of Continuing Tenofovir Versus Switching Entecavir to Tenofovir in Treatment of Chronic Hepatitis B Patients : A Comparative Study

Phase 3

Active, not recruiting

• Conditions: Chronic hepatitis B; Tenofovir; Entecavir; Switching

• Registration Number: TCTR20160125002
• Lead Sponsor: Chulabhorn Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-25
• Study Completion: 2017-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Chronic hepatitis B patient
2. serum HBsAg positive after received Entecavir or Tenofovir for more than 5 year

Exclusion Criteria

1. History of malignancy, except early stage skin cancer
2. Decompensated cirrhosis
3. Creatinine clearance < 50 ml/min
4. Kanofsky performance status < 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, 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