Status:

UNKNOWN

Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

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 lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study...

Eligibility Criteria

Inclusion

  • 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

  • Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Key Trial Info

Start Date :

September 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2019

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT03236584

Start Date

September 1 2015

End Date

March 30 2019

Last Update

August 2 2017

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