Completed

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

What is being tested

TDF

+ FTC/TDF Placebo

+ FTC/TDF

Drug

Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 75 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: September 2008

See protocol details

Summary

Principal SponsorGilead Sciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT00737568

Principal SponsorGilead Sciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

280 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsHepatitis B, ChronicDisease Attributes

Criteria

10 inclusion criteria required to participate

Chronic HBV infection, defined as positive serum HBsAg for at least 6 months

18 through 75 years of age, inclusive

HBV DNA ≥ 10^3 IU/mL

Receiving treatment with lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization; adefovir dipivoxil treatment of ≤ 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) was allowed

Show More Criteria

13 exclusion criteria prevent from participating

Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study

Males and females of reproductive potential who are not willing to use an effective method of contraception during the study

Alanine aminotransferase (ALT) ≥ 10 × the upper limit of the normal range (ULN)

Decompensated liver disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

TDF plus placebo to match FTC/TDF

Group II

Experimental

FTC/TDF plus placebo to match TDF

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers