Chronic Hepatitis B Clinical Trial
Official title:
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
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once
daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg
(FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera)
for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus
deoxyribonucleic acid [HBV DNA]).
Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind
treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of
open-label FTC/TDF which may be continued through the end of the 168-week treatment period
if there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with
confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may
continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the
investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in
subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may
discontinue the study and begin commercially available HBV therapy rather than initiate
open-label FTC/TDF.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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