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The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

NCT03308890 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2017-10-17

No results posted yet for this study

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 of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

Conditions

Interventions

DRUG

0.5mg Baraclude(entecavir)

0.5mg Baraclude (entecavir) QD for 6 months after cessation of TDF.

DRUG

0.5mg Baraclude(entecavir)

0.5mg Baraclude (entecavir) QD for 12 month after cessation of TDF.

Sponsors & Collaborators

  • China Medical University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Changhua Christian Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-07-01
Completion
2022-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308890 on ClinicalTrials.gov