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

A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132652

Enrollment

240

Registered

2005-08-22

Start date

2005-02-28

Completion date

2006-12-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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.

Interventions

DRUGLamivudine

DRUGTelbivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 Other protocol-defined inclusion criteria may apply.

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 Other protocol-defined

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026