Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir
Phase 3
- Conditions
- Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
- Interventions
- Registration Number
- NCT03236610
- Lead Sponsor
- Uijeongbu St. Mary Hospital
- Brief Summary
Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months
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 tenofovir plus entecavir tenofovir plus entecavir combination - tenofovir tenofovir monotherapy -
- Primary Outcome Measures
Name Time Method SVR at week 48 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
Trial Locations
- Locations (1)
Uijeongbu St. Mary Hospital
🇰🇷Uijongbu, Korea, Republic of