Hepatitis B Clinical Trial
Official title:
A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects With Chronic Hepatitis B Who Are Resistant to Lamivudine
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain
suppression of viral replication to prevent the emergence of complications, which requires
long-term therapy. Durable suppression of viral replication is achieved in the treatment of
chronic viral diseases by preventing of the emergence of drug-resistant mutations. The
clinical guidelines for the management of lamivudine resistant patients are variable. Some
recommend switching to another agent without cross-resistance, while others recommend adding
on another agent without cross-resistance. Limited clinical data exists to demonstrate
whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for
lamivudine resistant patients or if it should be used as part of a combination therapy
regimen.
This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir
DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants
with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or
without the rtL180M mutation) over a 240-week period. Participants in this study must be
receiving lamivudine treatment at the time of enrollment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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