Status:
UNKNOWN
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
Kaohsiung Medical University Chung-Ho Memorial Hospital
China Medical University Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir 1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R) 2. Long-term adefovir...
Detailed Description
Hepatitis B virus (HBV) is a partially double-stranded DNA virus. HBV infection can induce a spectrum of disease ranging from asymptomatic infection to severe chronic liver diseases, including cirrhos...
Eligibility Criteria
Inclusion
- HBsAg-positive for more than 6 months (HBeAg-positive or HBeAg-negative).
- Age \> 20 y/o.
- Under lamivudine/adefovir treatment for more than 1 year due to previous lamivudine resistance (LAM-R), current HBV DNA is undetectable (\< 20 IU/ml) during enrollment.
Exclusion
- HCV, HIV, HDV coinfection.
- Uncontrolled HCC, malignancy or decompensated liver cirrhosis (CTP score ≥ 7).
- Uremia patients or Creatinine ≥ 2 mg/dl.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01491295
Start Date
September 1 2012
End Date
December 1 2019
Last Update
April 1 2016
Active Locations (1)
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1
Taipei Veterans General Hospital-Division of Gastroenterology
Taipei, Taiwan, 11217