Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB)

NCT00804622

Chronic Hepatitis B

COMPLETED PHASE2

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

NCT00606099

Chronic Hepatitis B

WITHDRAWN PHASE4

Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

NCT00805675

Hepatitis B Virus

COMPLETED PHASE3

Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

NCT00640588

Hepatitis B, Chronic

COMPLETED PHASE3

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

NCT00376259

Hepatitis B

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Study cancelled: Withdrawn before enrollment of any participants

Group Type EXPERIMENTAL

Telbivudine

Intervention Type DRUG

Study cancelled: Withdrawn before enrollment of any participants

2

Study cancelled: Withdrawn before enrollment of any participants

Group Type EXPERIMENTAL

Adefovir

Intervention Type DRUG

3

Study cancelled: Withdrawn before enrollment of any participants

Group Type EXPERIMENTAL

Tenofovir

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telbivudine

Study cancelled: Withdrawn before enrollment of any participants

Intervention Type DRUG

Adefovir

Intervention Type DRUG

Tenofovir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
* Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C, hepatitis D or HIV
* Patient previously received nucleoside(tide) therapy other than adefovir
* Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No