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Switch to Tenofovir vs Continue LAM/ADV in LAM-R CHB
NCT01491295Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2012
- Primary completion
- Dec 2019
- Countries
- 1
- Sponsor
- Taipei Veterans General Hospital
- Modality
- Small Molecules
- Conditions
- Chronic Hepatitis B (CHB)
01
Overview
Phase 4, randomised, open-label trial of tenofovir disoproxil fumarate in Chronic Hepatitis B (CHB) (2 arms), sponsored by Taipei Veterans General Hospital. Primary endpoint: Incidence of virological breakthrough at 36 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tenofovir Monotherapy
Switch to Tenofovir disoproxil fumarate 300mg QD
Lamivudine + Adefovir
Continue Lamivudine 100mg QD + Adefovir 10mg QD
03
Who it enrols
Adult patients with HBsAg-positive chronic hepatitis B who have been under lamivudine/adefovir treatment for more than 1 year due to lamivudine resistance and have undetectable HBV DNA.
04
Endpoints
Primary
Incidence of virological breakthrough
Secondary
HBeAg seroconversion rate
Incidence of HBsAg loss
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