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

Completed · Phase 3

Conditions studied: Chronic Hepatitis B

In brief

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.

Key facts

Study ID

NCT00132652

Run by

Novartis

People needed

240

Starts

2005-02-01

Expected to finish

2006-12-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 exclusion criteria may apply.

Where it is running

• Study site — San Diego, California, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Westmead, Australia
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Beijing, China
• Study site — Nice, France
• Study site — Tel Aviv, Israel
• Study site — Auckland, New Zealand
• Study site — Singapore, Singapore
• Study site — Tainan, Taiwan
• Study site — Chiang Mai, Thailand
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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