An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-09-30

Brief Summary

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This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.

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Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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telbivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
* Patient is willing and able to comply with the study drug regimen and all other study requirements
* The patient is willing and able to provide written informed consent to participate in the extension study.

Exclusion Criteria

* Patient is pregnant or breastfeeding.
* Patient is co-infected with HCV, HDV, or HIV.
* History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No