Status:
UNKNOWN
The Effect of Entecavir Consolidation on Post-TDF Treatment Durability
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
China Medical University Hospital
Chang Gung Memorial Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation o...
Detailed Description
Long term nucleoside/nucleotide analogues (NAs) treatment is required in the treatment of chronic hepatitis B (CHB). According to current treatment guidelines from APASL 2015, NAs treatment can be sto...
Eligibility Criteria
Inclusion
- \>20 yrs old.
- No history of Lamivudine or telbivudine resistance.
- HBsAg positive for more than 6 months.
- HBeAg (-).
- HBeAg-negative CHB under TDF treatment for mora than 2 years and fulfilled APASL 2012 guideline's stopping rule: HBeAg (-): undetectable HBV DNA on 3 separate occasions at least 6 months apart.
Exclusion
- Lamivudine/telbivudine resistance.
- HBeAg (+).
- HIV, HCV co-infection.
- Under immunosuppressant treatment (including steroid and biologics).
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03308890
Start Date
November 1 2017
End Date
April 30 2022
Last Update
October 17 2017
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