A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combinatio...

Update Il y a 4 ans
Reference: EUCTR2005-003136-22

A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated with Adefovir Dipivoxil for Chronic Hepatitis B and having Persistent Viral Replication. Estudio aleatorizado de fase 2 a doble ciego para evaluar la eficacia, seguridad y tolerabilidad de la monoterapia de tenofovir disoproxil fumarato (DF) en comparación con la terapia combinada de emtricitabina más tenofovir DF a dosis fija, en pacientes que reciben adefovir dipivoxil en la actualidad para el tratamiento de la hepatitis B crónica y presentan replicación viral persistente

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Extract

To characterize the antiviral activity of tenofovir DF 300 mg QD versus emtricitabine 200 mg/tenofovir DF 300 mg QD in subjects currently being treated with adefovir dipivoxil for CHB who have persistent viral replication.


Inclusion criteria

  • Chronic hepatitis B,Hepatitis B Crónica