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NCT00132652 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00132652
Other study ID # NV-02B-019
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2005
Last updated February 21, 2017
Start date February 2005
Est. completion date December 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine

• Telbivudine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

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