Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

NCT ID: NCT00132652

Last Updated: 2017-02-23

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

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-12-31

Brief Summary

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This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lamivudine

Intervention Type DRUG

Telbivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented clinical history compatible with chronic hepatitis B
* Patient has compensated liver disease
* Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months

Exclusion Criteria

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C, hepatitis D or HIV
* Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Locations

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San Diego, California, United States

Site Status

New York, New York, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Westmead, , Australia

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Beijing, , China

Site Status

Nice, , France

Site Status

Tel Aviv, , Israel

Site Status

Auckland, , New Zealand

Site Status

Singapore, , Singapore

Site Status

Tainan City, , Taiwan

Site Status

Chiang Mai, , Thailand

Site Status

London, , United Kingdom

Site Status

Countries

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United States Australia Canada China France Israel New Zealand Singapore Taiwan Thailand United Kingdom

Other Identifiers

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NV-02B-019

Identifier Type: -

Identifier Source: org_study_id

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