Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir
Phase 3
- Conditions
- Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
- Interventions
- Registration Number
- NCT03236584
- Lead Sponsor
- Uijeongbu St. Mary Hospital
- Brief Summary
Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
- HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval
Exclusion Criteria
- Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lamivudine adefovir lamivudine plus adefovir combination - tenofovir Tenofovir Disoproxil Fumarate -
- Primary Outcome Measures
Name Time Method SVR 48 WEEK Proportion of patients with a sustained virological response (serum HBV DNA \<20 IU/mL) at week 48
- Secondary Outcome Measures
Name Time Method