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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The Effect of Entecavir Consolidation on Post-TDF Treatment Durability | DecenTrialz