Status:
UNKNOWN
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir
Lead Sponsor:
Uijeongbu St. Mary Hospital
Conditions:
Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03236610
Start Date
January 1 2016
End Date
June 30 2019
Last Update
August 2 2017
Active Locations (1)
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1
Uijeongbu St. Mary Hospital
Uijongbu, South Korea